Paddle lead maximizing lateral target points across a peripheral nerve

ABSTRACT

The present disclosure involves a medical system. The medical system an implantable lead configured to deliver an electrical stimulation therapy for a patient. The lead includes an elongate lead body that is configured to be coupled to a pulse generator that generates electrical stimulations pulses as part of the electrical stimulation therapy. The lead also includes a paddle coupled to the lead body. The paddle contains a plurality of electrodes that are each configured to deliver the electrical stimulation pulses to the patient. The plurality of electrodes is arranged into at least three columns that each include a respective subset of the electrodes. The plurality of electrodes each includes a unique centerline, wherein the centerlines extend in directions transverse to the columns.

PRIORITY DATA

The present application is a utility application of provisional U.S.Patent Application No. 61/841,965, filed on Jul. 2, 2013, entitled“Stimulation Apparatuses, Devices, Systems, and Methods,” the disclosureof which is hereby incorporated by reference in its entirety.

FIELD

Various embodiments described herein relate to the field of implantablemedical devices, and methods of communicating therewith.

BACKGROUND

As medical device technologies continue to evolve, neurostimulatordevices have gained much popularity in the medical field.Neurostimulator devices are typically battery-powered devices that aredesigned to deliver electrical stimulation to a patient. Through properelectrical stimulation, the neurostimulator devices can provide painrelief for patients. In effect, the electrical signals sent by theneurostimulator devices “mask” or modify the pain signals before thepain signals reach the patient's brain. As a result, the patient mayfeel only a tingling sensation (known as “Paresthesia) in the area thatis stimulated instead of pain. For example, peripheral nerve stimulationhas been used to treat chronic pain emanating from a patient'sextremity, such as in the patient's arm and/or leg. A typical peripheralneurostimulator (PNS) device may include one or more integrated circuitchips containing the control circuitry and neurostimulation circuitry.The PNS device may also include a plurality of electrodes that are incontact with different areas of a patient's body. The PNS devicetypically includes a battery, either permanent or rechargeable, that isutilized to power the stimulation circuitry and the externalcommunications. Controlled by the control circuitry within theneurostimulator, the electrodes are each capable of deliveringelectrical stimulation to their respective target contact areas. Thus,the patient can use the PNS device to stimulate areas in a localizedmanner.

In spite of recent advances, conventional PNS devices still have variousshortcomings. As an example, the nerves in a spinal cord are typicallyarranged more orderly and run along a linear path, whereas the nerves tobe stimulated in peripheral nerve stimulation usually wind tortuouslyalong a neurovascular bundle. Therefore, a typical paddle lead for aconventional PNS device or for spinal cord stimulation does not offerthe flexibility and versatility needed to stimulate the target nervefibers for peripheral nerve stimulation, as they are not configured toallow electrical stimulation energy to follow the tortuous peripheralnerve targets selectively. As another example, conventional PNS devicestypically require an antenna to receive telemetry signals and a separatecharging coil to receive charging signals. As a result, PNS design ismore complex and more expensive. As yet another example, conventionalPNS devices typically do not employ sophisticated power maximizationtechniques to reduce power consumption. Consequently, conventional PNSdevices tend to have battery life that does not last as long as desired.The short battery life may lead to user dissatisfaction. As yet anotherexample, it may be difficult to determine a target nerve site forapplying stimulation.

As a result, although existing systems and methods of peripheralneurostimulation have been generally adequate for their intendedpurposes, they have not been entirely satisfactory in every aspect.

SUMMARY

One aspect of the present disclosure involves an implantable leadconfigured to deliver an electrical stimulation therapy for a patient.The lead includes an elongate lead body that is configured to be coupledto a pulse generator that generates electrical stimulations pulses aspart of the electrical stimulation therapy. The lead also includes apaddle coupled to the lead body. The paddle contains a plurality ofelectrodes that are each configured to deliver the electricalstimulation pulses to the patient. The plurality of electrodes isarranged into at least three columns that each include a respectivesubset of the electrodes. The plurality of electrodes each includes aunique centerline, wherein the centerlines extend in directionstransverse to the columns.

Another aspect of the present disclosure involves an implantable leadconfigured to deliver an electrical stimulation therapy for a patient.The lead includes an elongate lead body that is configured to be coupledto a pulse generator that generates electrical stimulations pulses aspart of the electrical stimulation therapy. The lead also includes apaddle coupled to the lead body. The paddle contains a plurality ofelectrodes that are each configured to deliver the electricalstimulation pulses to the patient. The plurality of electrodes each havea respective first centerline extending along a first direction and arespective centerline extending along a second direction different fromthe first axis. A substantial majority of the first centerlines are notaligned in the first direction with any of the other first centerlines.A substantial majority of the second centerlines are not aligned in thesecond direction with any of the other second centerlines.

Yet another aspect of the present disclosure involves an implantablelead configured to deliver an electrical stimulation therapy for apatient. The lead includes an elongate lead body that is configured tobe coupled to a pulse generator that generates electrical stimulationspulses as part of the electrical stimulation therapy. The lead alsoincludes a paddle coupled to the lead body. The paddle contains aplurality of electrodes that are each configured to deliver theelectrical stimulation pulses to the patient. The electrodes collectivedefine a stimulation region on the paddle. A substantial majority oflinear paths across the stimulation region intersect with at least oneof the electrodes.

Another aspect of the present disclosure involves a medical device forproviding an electrical stimulation therapy for a patient. The medicaldevice includes a coil configured to receive both inductive chargingsignals and telemetry signals. The inductive charging signals are in afirst frequency band. The telemetry signals are in a second frequencyband that is substantially higher than the first frequency band. Themedical device includes inductive charging circuitry configured toprovide electrical power to the medical device via the inductivecharging signals. The medical device includes telemetry circuitryconfigured to conduct telecommunications with external device via thetelemetry signals. The medical device includes a first component that iselectrically coupled between the coil and the inductive chargingcircuitry. The first component is configured to allow the inductivecharging signals to pass through. The medical device includes a secondcomponent that is electrically coupled between the coil and thetelemetry circuitry. The second component is configured to substantiallyblock the inductive charging signals while allowing the telemetrysignals to pass through.

Another aspect of the present disclosure involves a medical system forproviding an electrical stimulation therapy for a patient. The medicalsystem includes an electronic programmer configured to generate firsttelemetry signals that contain stimulation programming instructions foran implantable pulse generator (IPG) and second telemetry signals forwaking up the IPG. The medical system includes the IPG configured togenerate electrical pulses in response to the stimulation programminginstructions. The IPG contains an antenna configured to receive thefirst telemetry signals, the second telemetry signals, and inductivecharging signals. The inductive charging signals are in a firstfrequency band, the first telemetry signals are in a second frequencyband that is substantially higher than the first frequency band, and thesecond telemetry signals are in a third frequency band that issubstantially higher than the second frequency band. The IPG contains aninductive charging circuitry configured to provide electrical power tothe medical device via the inductive charging signals. The IPG containstelemetry circuitry configured to conduct telecommunications withexternal device via the telemetry signals. The IPG contains a firstcircuit that is electrically coupled between the antenna and theinductive charging circuitry. The first circuit contains one or moreelectronic components that create a resonant frequency centered aroundthe first frequency band. The IPG contains a second circuit that iselectrically coupled between the antenna and the telemetry circuitry.The second circuit is configured to substantially reject the inductivecharging signals and the second telemetry signals while allowing thefirst telemetry signals to pass through. The IPG contains a thirdcircuit that is electrically coupled between the antenna and thetelemetry circuitry and in parallel with the second circuit. The thirdcircuit is configured to reject the inductive charging signals and thefirst telemetry signals while allowing the second telemetry signals topass through.

Another aspect of the present disclosure involves a method of providingdiscrimination for a plurality of types of input signals received from asingle antenna. The method includes receiving, via the single antenna,inductive charging signals and first telemetry signals. The inductivecharging signals are in a first frequency band, the first telemetrysignals are in a second frequency band that is substantially higher thanthe first frequency band. The method includes generating, via a firstcircuit coupled to the single antenna, a resonant frequencysubstantially near the first frequency band such that the first circuitallows the inductive charging signals to pass through while attenuatingthe first telemetry signals. The method includes rejecting, via a secondcircuit coupled to the single antenna, the inductive charging signalswhile allowing the first telemetry signals to pass through.

Another aspect of the present disclosure involves a medical device forproviding an electrical stimulation therapy for a patient. The medicaldevice includes telemetry circuitry configured to receive programminginstructions via telecommunications conducted with an electronicprogrammer. The medical device includes stimulation circuitry configuredto provide, in response to the received programming instructions, aplurality of electrical pulses to be delivered to the patient as a partof the electrical stimulation therapy. The stimulation circuitrycontains a microcontroller configured to generate the electrical pulses.Each electrical pulse includes a primary phase, an interphase after theprimary phase, and a recovery phase after the primary phase. Consecutiveelectrical pulses are separated by a standby period. The medical deviceincludes power supply circuitry configured to provide electrical powerto the telemetry circuitry and the stimulation circuitry. Themicrocontroller is configured to operate in an active mode during atleast one of: the primary phase and the interphase, and themicrocontroller is configured to operate in a power-conservation modeduring a substantial majority of the standby period. The microcontrollerconsumes substantially less power when operating in thepower-conservation mode than in the active mode.

Another aspect of the present disclosure involves a medical system forproviding an electrical stimulation therapy for a patient. The medicalsystem includes an electronic programmer configured to generatestimulation programming instructions for an implantable pulse generator(IPG). The medical system includes the IPG. The IPG comprises telemetrycircuitry configured to receive the programming instructions viatelecommunications conducted with the electronic programmer. The IPGcomprises stimulation circuitry configured to provide, in response tothe received programming instructions, a plurality of electrical pulsesto be delivered to the patient as a part of the electrical stimulationtherapy. The stimulation circuitry contains a microcontroller configuredto generate the electrical pulse. Each electrical pulse includes aprimary phase, an interphase after the primary phase, and a recoveryphase after the primary phase. Consecutive electrical pulses areseparated by a standby period. The IPG comprises power supply circuitryconfigured to provide electrical power to the telemetry circuitry andthe stimulation circuitry. The microcontroller is configured to operatein an active mode during at least one of: the primary phase and theinterphase, and the microcontroller is configured to operate in apower-conservation mode during a substantial majority of the standbyperiod. The microcontroller consumes substantially less power whenoperating in the power-conservation mode than in the active mode.

Another aspect of the present disclosure involves a method of providingan electrical stimulation therapy for a patient. The method includesreceiving programming instructions from an electronic programmer. Themethod includes generating, via a microcontroller and in response to thereceived programming instructions, a plurality of electrical pulses tobe delivered to the patient as a part of the electrical stimulationtherapy. Each electrical pulse includes a primary phase, an interphaseafter the primary phase, and a recovery phase after the primary phase.Consecutive electrical pulses are separated by a standby period. Thegenerating of the electrical pulses comprises: operating themicrocontroller in an active mode during at least one of: the primaryphase and the interphase, and operating the microcontroller in apower-conservation mode during a substantial majority of the standbyperiod. The microcontroller consumes substantially less power whenoperating in the power-conservation mode than in the active mode.

BRIEF DESCRIPTION OF THE DRAWINGS

Aspects of the present disclosure are best understood from the followingdetailed description when read with the accompanying figures. It isemphasized that, in accordance with the standard practice in theindustry, various features are not drawn to scale. In fact, thedimensions of the various features may be arbitrarily increased orreduced for clarity of discussion. In the figures, elements having thesame designation have the same or similar functions.

FIG. 1 is stylized overview of the human nervous system.

FIG. 2 is a simplified block diagram of an example medical systemaccording to various embodiments of the present disclosure.

FIGS. 3A-3B illustrate stylized views of various portions of the humanbody with example peripheral neurostimulators implanted according toembodiments of the present disclosure.

FIGS. 4-5 illustrate an example peripheral neurostimulator according toan embodiment of the present disclosure.

FIGS. 6A-6C illustrate an example programmer for a neurostimulatoraccording to an embodiment of the present disclosure.

FIG. 7 illustrates a simplified block diagram of an example peripheralneurostimulator according to an embodiment of the present disclosure.

FIG. 8 is a legend showing how the FIGS. 8A-8L are arranged together.FIGS. 8A-8L illustrates a circuit schematic of the peripheralneurostimulator of FIG. 7 according to an embodiment of the presentdisclosure.

FIG. 9 illustrates example peripheral nerve bundles being stimulated bya paddle lead according to an embodiment of the present disclosure.

FIGS. 10-14 illustrate example paddle leads for delivering electricalstimulation to peripheral nerve according to various embodiments of thepresent disclosure.

FIGS. 15A-15C illustrate a conductive element used by a peripheralneurostimulator according to various embodiments of the presentdisclosure.

FIG. 16 illustrates a simplified block diagram of components of theperipheral neurostimulator used to provide signal discriminationaccording to various embodiments of the present disclosure.

FIG. 17 illustrates circuit schematics of the various components of theperipheral neurostimulator used to provide signal discriminationaccording to an embodiment.

FIG. 18 is a simplified flowchart illustrating a method of providingdiscrimination for a plurality of types of signals received from asingle conductive element according to an embodiment of the presentdisclosure.

FIG. 19 illustrates the power-reduction approaches employed by aperipheral neurostimulator during a passive recovery stimulation pulseaccording to an embodiment of the present disclosure.

FIG. 20 illustrates the power-reduction approaches employed by aperipheral neurostimulator during an active recovery stimulation pulseaccording to an embodiment of the present disclosure.

FIG. 21 is a simplified flowchart illustrating a method of reducingpower consumption for a peripheral neurostimulator according to anembodiment of the present disclosure.

DETAILED DESCRIPTION

It is to be understood that the following disclosure provides manydifferent embodiments, or examples, for implementing different featuresof the invention. Specific examples of components and arrangements aredescribed below to simplify the present disclosure. These are, ofcourse, merely examples and are not intended to be limiting. Variousfeatures may be arbitrarily drawn to different scales for simplicity andclarity.

The human nervous system includes a complex network of neurologicalstructures that extend throughout the body. As shown in FIG. 1, thebrain interconnects with the spinal cord which branches into thebrachial plexus near the shoulders and the lumbar plexus and sacralplexus in the lower back. The limb peripheral nerves of the arms extenddistally from the brachial plexus down each arm. Similarly, the limbperipheral nerves of the legs extend distally from the lumbar plexus andsacral plexus. A number of the larger limb peripheral nerves areidentified in FIG. 1. As discussed further below, certain aspects of thepresent invention are particularly well suited to stimulation of limbperipheral nerves, including those identified in FIG. 1.

FIG. 2 illustrates a simplified block diagram of a medical system 20 toprovide an example context of the various aspects of the presentdisclosure. The medical system 20 includes an implantable medical device30, an external charger 40, a patient programmer 50, and a clinicianprogrammer 60. The implantable medical device 30 can be implanted in apatient's body tissue. The implantable medical device 30 may include animplantable pulse generator (IPG) 70. In some embodiments, the IPG 70 isa peripheral neurostimulator (PNS) device. The IPG 70 is coupled to oneend of an implantable lead 75. The other end of the implantable lead 75includes multiple electrode surfaces 80 through which electrical currentis applied to a desired part of a body tissue of a patient. Theimplantable lead 75 incorporates electrical conductors to provide a pathfor that current to travel to the body tissue from the IPG 70. Althoughonly one implanted lead 75 is shown in FIG. 1, it is understood that aplurality of implanted leads may be attached to the IPG 70. Furthermore,the type of implanted lead that may be used in the medical system 20 isnot limited to the embodiment shown in FIG. 1. For example, a paddlelead may be implemented in certain embodiments.

The external charger 40 of the medical device system 20 provideselectrical power to the IPG 70. The electrical power may be deliveredthrough a charging coil 90. In some embodiments, the charging coil canalso be an internal component of the external charger 40. The IPG 70 mayalso incorporate power-storage components such as a battery or capacitorso that it may be powered independently of the external charger 40 for aperiod of time, for example from a day to a month, or longer, dependingon the power requirements of the therapeutic electrical stimulationdelivered by the IPG.

The patient programmer 50 and the clinician programmer 60 may beportable handheld devices that can be used to configure the IPG 70 sothat the IPG 70 can operate in a certain way. The patient programmer 50is used by the patient in whom the IPG 70 is implanted. The patient mayadjust the parameters of the stimulation, such as by selecting aprogram, changing its amplitude, frequency, and other parameters, and byturning stimulation on and off. The clinician programmer 60 is used by amedical personnel to configure the other system components and to adjuststimulation parameters that the patient is not permitted to control,such as by setting up stimulation programs among which the patient maychoose, selecting the active set of electrode surfaces in a givenprogram, and by setting upper and lower limits for the patient'sadjustments of amplitude, frequency, and other parameters. It is alsounderstood that although FIG. 2 illustrates the patient programmer 50and the clinician programmer 60 as two separate devices, they may beintegrated into a single programmer in some embodiments.

FIGS. 3A-3B illustrate various example regions of the human body withinwhich a peripheral PNS device may be implanted. For example, referringto FIG. 3A, a lower leg 100 of a patient is illustrated. As anembodiment of the implantable medical device 30 discussed above withreference to FIG. 2, a PNS device 105 is implanted in the lower leg 100,for example, near the calf muscles. Through an elongate lead body 110,the PNS device 105 is electrically coupled to implanted electrodes 112.The electrodes are positioned for stimulation of the posterior tibialnerve 115. In the illustrated embodiment, the PNS device 105, the leadbody 110, and the implanted electrodes 112 all reside below the knee andare contained within the length of the tibia 122 and the fibula 124. Inother words, the lead body 110 does not traverse a joint as it extendsbetween the PNS device 105 and the implanted electrode 112. In theillustrated embodiment, the PNS device 105, the lead body 110, and theimplanted electrodes 112 are positioned between a knee joint and anankle joint.

Referring now to FIG. 3B, another example PNS device 150 is implantedalong the humerous bone. The PNS device 150 is coupled to implantedelectrodes 154 through a lead body 152. The PNS device, the lead body152, and the implanted electrodes 154 are positioned along the humerousbone without extending into or across the adjacent joints in theshoulder or elbow. Similarly, another example PNS device 160 may beimplanted along and within the length of the radius and ulna bones. ThePNS device 160 is coupled to implanted electrodes 164 through a leadbody 162. The PNS device 160, the lead body 162, and the implantedelectrodes 164 are implanted under the skin of the forearm but withoutany of the components extending into the adjacent joints of the elbowand the wrist. As yet another example, a PNS device 180 may be implantedalong a metacarpus bone in the hand. The PNS device 180 is coupled toimplanted electrodes 184 through a lead body 182. The implantation ofthe PNS device 180, the lead body 182, and the implanted electrodes 184is configured such that none of them extends across an adjacent joint inthe wrist or the fingers.

It is understood that FIGS. 3A-3B merely illustrate several examplesites of the body in which a PNS device may be implanted to stimulateone or more target nerves (such as the posterior tibial nerve in FIG.3A). A PNS device may also be implanted in a number of other differentperipheral nerves locations shown in FIG. 1. For instance, a PNS devicemay be implanted in a patient's arms to stimulate one or more of themedian, ulnar, radial, and brachial plexus nerves, as well as in apatient's legs to stimulate one or more of the tibial, saphenous,sciatic, and femoral nerves. For reasons of simplicity, theseconfigurations are not specifically illustrated herein.

Referring now to FIGS. 4-5, a PNS device 200 is illustrated according toan embodiment of the present disclosure. In general, peripheral nervestimulation is a technique configured to provide medical therapy fordifferent diseases and/or to treat different types of pain. Dependingupon the therapeutic application, peripheral nerve stimulation systemsgenerally seek to activate only motor nerves (e.g., for functionalpurposes, such as dorsiflexion for a dropped foot, or a grasp for upperextremity hemiplegia) or only sensory nerves (e.g., for neuropathic painmanagement).

In treating pain, stimulation of innocuous sensory fibers in theperiphery ostensibly affects pain transmission to the brain via the GateControl Theory. Clinically, stimulation of these fibers usually resultsin a comfortable, moderate ‘buzzing’ sensation in the area of pain,termed paresthesia.

In general, peripheral nerve stimulation can utilize relatively simplestimulation techniques to provide excellent therapy. However, PNStherapy today is generally delivered by equipment designed for spinalcord stimulation (SCS). Spinal cord stimulation equipment utilizes largeand overpowered implantable pulse generators (IPGs) designed not forstimulating peripheral nerves, but is designed to deliver electricalpulses to the spinal column. IPGs designed for SCS is also placed inlarge pockets in the lower back/upper buttock, rather than beingimplanted near the targeted peripheral nerve for electrical stimulation.These poorly adapted technologies for peripheral nerve therapy can causesignificant tissue morbidity in the need to route the wires between thetargeted peripheral nerve and the distantly located IPG unit. This, inturn, can result in frequent device failure (and thus therapy failure)due largely to lead migration and breakage. In many cases where SCSequipment was used for PNS, a large percentage of patients neededrevision surgeries to address issues with the SCS IPG and leads.Additionally, while some peripheral nerve pain can be addressed bystimulating the nerve root through SCS of the spinal column, it can bedifficult to achieve effective pain relief with respect to a targetednerve and anatomy without affecting nearby, undesired areas.

To overcome the limitations associated with using SCS equipment toperform PNS, the present disclosure provides a small, flexible PNSsystem—an example embodiment of which includes the PNS device 200 shownin FIGS. 4-5—that can be made simple and small enough to be deployed ina minimally invasive surgical procedure, locally to the region of thetargeted nerves, thereby avoiding tunneling through tissue to remoteregions of the anatomy.

In some embodiments, the PNS system is characterized by a low partscount, low cost-of-goods, ease of manufacturability, a high energydensity long lasting rechargeable battery, use of known biocompatiblematerials, compatibility with industry preferred electrode/lead systems,and a hermetic implantable device geometry that is well suited for mostpreferred anatomical locations. In some embodiments, the system,although simplified, is still flexible enough to handle a wide range ofunilateral and bilateral applications, has high stimulation power outputcapability, covers accepted ranges of therapeutic waveform frequency andduration, can drive multiple leads of eight or more contacts each, andutilizes custom software applications reconfigurable for the differentclinical applications (e.g., pain, incontinence, depression, epilepsy,etc.).

In some embodiments, the PNS system of the present disclosure includesthe PNS device 200 in the form of a hermetically-sealed implantablepulse generator. The PNS device 200 has a miniature form factor. Forexample, the PNS device 200 may have a total volume of less than 5 cubiccentimeters and a thickness less than 5 millimeters. To illustrate thesmall dimensions of the PNS device 200, FIG. 5 shows the PNS device 200next to a quarter. As can be seen in FIG. 5, the PNS device 200 isshorter than the quarter and not much longer either. Such small packagesize of the PNS device 200 enables comfortable and cosmeticallyattractive placement of the PNS device 200 on the limbs of the patient.

Furthermore, the PNS device 200 offers one or more of the followingfeatures:

-   -   Active can/enclosure technology that allows for broader        stimulation fields;    -   Deep drawn small but shallow rectangular form factor for the can        that allows for ease of manufacture and low cost;    -   Connects to proximal ends of “industry standard” electrodes,        which have become preferred for ease of handling        characteristics;    -   Single piece high reliability connector stack;    -   High density pin-less hermetic feedthrough connection system;    -   Two reversibly connectible header ports enable connection of two        leads for multi-region stimulation targeting, nominally distal        from implanted package;    -   High number of contacts per lead to allow for a wide range of        lead designs (for instance, 8 tightly spaced contacts per lead)        and different therapeutic applications (for instance, chronic        intractable pain).

In addition to the PNS device 200, the PNS system of the presentdisclosure may also include an external stimulator used for trialtherapy periods, one or more leads with corresponding electrodes, anextension for a lead/electrode, accessories such as lead anchors andsurgical procedure tools, a remote control and pulse generator chargerthat may be combined into one device, and/or a remote controller forphysician or patient programming use.

For example, FIGS. 6A-6C illustrate an example electronic programmer 250configured to send programming instructions to the PNS device 200. ThePNS device 200 generates a corresponding electrical stimulation therapy(e.g., a series of electrical stimulation pulses) in response to thereceived programming instructions. In certain embodiment, the electronicprogrammer 250 is configured to be used by either the patient or ahealthcare professional. As such, the electronic programmer 250 may beviewed as an embodiment of the patient programmer 50 and the clinicianprogrammer 60 integrated together as a single device.

As is shown in FIG. 6A, the electronic programmer 250 has a“smartphone-like” industrial design. For example, the electronicprogrammer 250 has a touchscreen (e.g., a capacitive touchscreen)graphical user interface with virtual buttons and input/output fields.The electronic programmer 250 may also have tactile buttons that providean immediate control input to the programmer 250 for quick and simplecore system functions. Such “smartphone-like” design reduces the stigmaof using a medical device. The “smartphone-like” design of theelectronic programmer also makes it easier for the user of theelectronic programmer to learn how to use it quickly, since smartphoneshave become very popular, and most people are comfortable interactingwith a smartphone-like user interface.

Aside from its elegant and intuitive industrial design, the electronicprogrammer 250 also offers flexible functionalities. For example, theelectronic programmer 250 may be configurable from patient to patient,according to the patient's level of technical competence and/or comfort.The electronic programmer 250 may also be reconfigurable via firmwarefor different therapeutic applications (for instance, chronicintractable pain). Furthermore, the electronic programmer 250 may havemultiple user modes: e.g., patient programming and patient charging mode(both configurable by a clinician), clinician mode, engineering mode,diagnostic mode, etc.

Referring to FIG. 6B, the electronic programmer 250 also includes anonboard battery 260. In the illustrated embodiment, the battery 260 issealed within the housing of the electronic programmer 250 and isnon-removable. In alternative embodiments, however, the battery 260 maybe user-removable. The battery 260 is a rechargeable battery. In variousembodiments, the battery 260 has a capacity ranging from about 400milli-amp hours (mAh) to about 4000 mAh, for example with a capacityaround 2700 mAh. The rechargeable nature of the battery 260 allows it tohave a reduced size and mass.

The electronic programmer 250 also has a USB port 265, which allows theelectronic interchange (e.g., telemetry or power) between the electronicprogrammer 250 and external devices. For example, referring to FIG. 6C,a charger 270 is coupled to the USB port 265 of the electronicprogrammer 250 through a USB cable 280. The battery 260 may providepower to the charger 270, which contains internal charging electronicsand a charge coil for inductively charging the PNS device 200 discussedabove. This type of power/charging configuration shown in FIGS. 6B-6Cgreatly simplifies patient tasks with respect to charging the PNS device200, as patients only has a few things to manage. In addition, chargingcan be done at any time as needed and while the patient isambulatory/mobile.

The electronic programmer 250 and the charger 270 are also bothimplemented in small and lightweight packages. For example, they mayeach have a thickness less than about 10 millimeters (mm). The smallsize of the electronic programmer 250 and the charger 270 enablescomfortable, convenient, and cosmetically attractive wearing of theelectronic programmer 250 and/or the charger 270 on a patient's limb,for example with a detachable belt or band. In some embodiments, therelative simplicity and versatility of the electronic programmer 250discussed above reduce or eliminate the need for a cumbersome separateclinician programmer.

The various sections and components of the PNS device 200 will now bediscussed in more detail below.

Referring to FIG. 7, a simplified block diagram of the PNS device 200 isillustrated. The PNS device 200 includes a power supply circuitrysection 300, a stimulation circuitry section 305, and a telemetrycircuitry section 310. The power supply circuitry section 300 includesan inductive charging component 320. In some embodiments, the chargingcomponent 320 includes a coil for receiving power/energy inductivelyfrom an external charger, for example from the charger 270 discussedabove with reference to FIG. 6C. In some embodiments, the inductiveenergy (i.e., the charging signal) received from the inductive chargingcomponent 320 ranges from about 0.1 volts to about 5 volts in amplitude,and it has a frequency range that is within one of the Industrial,Scientific, and Medical (ISM) radio bands. For example, in someembodiments, the inductive energy is in a 13.56 Mhz band, that is, itranges from 13.553 Mhz to 13.567 Mhz with a center frequency at 13.56Mhz. In other embodiments, the inductive energy may be in alternativeISM radio bands.

The power supply circuitry section 300 further includes a circuitnetwork 325. The circuit network includes microelectronic componentsthat provide a resonant frequency at or near the center frequency of theISM radio band associated with the inductive energy received by thecharging component 320. Thus, in the embodiments where the inductiveenergy is in the 13.56 Mhz ISM radio band, the microelectroniccomponents of the circuit network 325 provide a resonant frequency at ornear 13.56 Mhz. This resonant frequency allows the inductive energy topass through, but effectively rejects signals from outside the selectedISM radio band. For example, telemetry signals that have much higher (orlower) frequencies than the selected ISM radio band will be blocked bythe circuit network 325. In this manner, the circuit network 325 mayfunction similar to a filter. The various aspects of the circuit network325 will be discussed in greater detail below.

The power supply circuitry section 300 also includes a charging circuit330 that is electrically coupled to the inductive charging component320. The charging circuit 330 includes various electronic componentsthat convert the inductive energy received from the inductive chargingcomponent 320 into a direct current (DC) voltage. In some embodiments,the charging circuit 330 may include a voltage booster that can converta lower input voltage to a higher output voltage, so as to adequatelycharge a battery 340 coupled thereto. In some embodiments, the battery340 is configured to output a DC output voltage ranging from about 3.5volts to about 4 volts. Thus, the charging circuit 330 can boost aninput voltage (e.g., received from the inductive charging component 320)to meet or exceed the requisite DC output voltage of the battery 340.

The power supply circuitry section 300 further includes an energyharvesting component 350 that is configured to supply power to thebattery 340. As is illustrated, the output of the energy harvestingcomponent 350 is electrically coupled to the charging circuit 330, whichboosts the energy harvested by the energy harvesting component to alevel that can be used to charge the battery 340. In some embodiments,the energy harvesting component 350 includes a thermoelectric generator(TEG) that converts the body heat of the patient (inside whom the PNSdevice 200 is implanted) to electrical energy. The converted electricalenergy may then be used to charge the battery 340 (after being boostedup by the charging circuit 330). In some other embodiments, the energyharvesting component 350 may also include circuitry to convert infraredlight and/or vibration and movement of the patient into electricalenergy. In various embodiments, the electrical energy harvested by theenergy harvesting component 350 may exceed about 100 millivolts (mV).

The power supply circuitry section 300 also includes a voltagedown-converter 360 coupled to the battery 340. The voltagedown-converter 360 converts the nominal DC output voltage of the battery340 to a lower level suitable for powering some of the electroniccircuitry of the PNS device 200, such as a microcontroller, amplifiers,and telemetry circuitry (discussed below in more detail). For example,in embodiments where the DC voltage output of the battery 340 is about 4volts, the down-converter 360 reduces it to about 2.7 volts. In theillustrated embodiment, 2.7 volts is a sufficient voltage to powerelectronic components such as the microcontroller, amplifiers, or thetelemetry circuitry, and thus there is no need to waste the highervoltage output (e.g., 4 V) produced by the battery 340. In other words,the voltage down-converter 360 saves energy by down-converting the DCvoltage output of the battery 340. In some embodiments, the voltagedown-converter 360 includes a buck regulator or a low-dropout (LDO)linear regulator.

The power supply circuitry section 300 further includes a voltageup-converter 370 coupled to the battery 340. The voltage down-converter370, when turned on, converts the nominal DC output voltage of thebattery 340 to a higher level to enable high output voltage compliancefor electrical stimulation. In more detail, the electrical stimulationpulses for the stimulation therapy may require higher voltages (e.g., ashigh as 12 volts) than the nominal DC voltage output of the battery 340.In these cases, the voltage up-converter 370 may be activated to boostthe DC output voltage of the battery 340, for example from 4 volts to 8volts or 12 volts, or at a fractional value in between. In theillustrated embodiment, the voltage up-converter 370 supplies power tostimulation circuitry (e.g., stimulation driver) that will be discussedbelow in more detail. To accomplish the voltage boost, the voltageup-converter 370 includes a charge pump in the present embodiment, butit is understood that it may include alternative types of voltageup-converters in alternative embodiments.

It is understood that the specific voltage values here are providedmerely as an example and are not intended to be limiting. For example,the voltage down-converter 360 may down-convert a 4 volt DC output ofthe battery 340 to a 2.3 volt DC voltage that will then be supplied tocertain electronic circuitry of the PNS device 200. As another example,the voltage up-converter 370 may up-convert a 4 volt DC output of thebattery 340 to a number that is a fraction (greater than 1) of the 4volt DC voltage.

The stimulation circuitry section 305 includes a microprocessor ormicrocontroller 400 (referred to as a microcontroller hereinafter) thatis powered by the output of the voltage down-converter 360. Themicrocontroller 400 controls various operations of the PNS device 200.For example, the microcontroller 400 is configured to generateelectrical stimulation pulses in response to programming instructionsreceived from a programmer, such as from the electronic programmer 250discussed above with reference to FIGS. 6A-6C. In various embodiments,the microcontroller 400 may include a microcontroller chip (e.g., anapplications processor) with internal instruction and data caches,multimedia capabilities, external memory interfacing, and interfacingflexibility.

The microcontroller 400 may also include memory such as FLASH memory, aread-only memory (“ROM”), a random access memory (“RAM”), anelectrically erasable programmable read-only memory (“EEPROM”), a harddisk, an optical disk, or another suitable magnetic, optical, physical,or electronic memory device. In some embodiments, the microcontroller400 includes a double data rate (DDR2) synchronous dynamic random accessmemory (SDRAM) for storing data relating to and captured during theoperation of the portable electronic device 90. Of course, other typesof data storage devices may be used in place of the data storage devicesdiscussed herein. It is understood that the different types of memorydiscussed above may be integrated into the microcontroller chipdiscussed above or may be separately implemented from themicrocontroller chip. Software code, firmware code, or other types ofprogram modules and applications may be stored on the memory and may beexecuted to perform certain tasks, such as generating the stimulationpulses.

According to some embodiments, the microcontroller 400 is configured toperform one or more of the following tasks:

-   -   Generate stimulation waveforms with internal 12-bit DAC, contact        combinations, and manages compliance voltage    -   Manage bidirectional telemetry & external communications    -   Manage sensing for impedance, battery voltage, and physiological        signals    -   Store data for diagnostics and device use tracking    -   Store Code, bootloader, and other suitable data in onboard FLASH        and RAM    -   Enter various power-conservation consumptions modes to reduce        power consumption    -   Manages emergency ON/OFF states from a magnetic switch    -   Reconfigure system with a new firmware download

As is shown in FIG. 7, the microcontroller 400 includes amicrocontroller core 410. Most of the functions of the microcontroller400 discussed above may be performed by, or at least in part by, themicrocontroller core 410. As such, the microcontroller core 410 is apower-hungry device and consumes significantly more power than the restof the components of the microcontroller 400. In order to save power,the microcontroller 400 also includes a direct memory access (DMA) unit420. In some embodiments, the DMA unit 420 is a task handler that canoperate independently from the microcontroller core 410. For example,the DMA unit 420 may be capable of sending instructions to peripherals(discussed in more detail below) within the microcontroller 400, withouthaving to go through the microcontroller core 410. One benefit of usingthe DMA unit 420 is that it consumes substantially less power than themicrocontroller core 410. For example, in some embodiments, the DMA unit420 consumes less than 10% of the power of the microcontroller core 410.Therefore, according to various aspects of the present disclosure, theDMA unit 420 may be utilized to execute certain simple tasks while themicrocontroller core 410 is turned off in order to reduce powerconsumption.

The microcontroller 400 further includes a plurality of peripherals,channels, or buses. For example, the microcontroller 400 may include adigital-to-analog converter (DAC) to generate the waveforms for theelectrical stimulation pulses. The microcontroller 400 may also includean analog-to-digital converter (ADC) to convert an analog feedbacksignal to digital numbers. The microcontroller 400 may also include aVBOOST_EN line that is electrically coupled to the voltage up-converter370. When the VBOOST_EN line is enabled, the voltage up-converter 370 isactivated and doubles or triples the DC output voltage from the battery340, or scales up the DC output voltage from the battery 340 by afractional number greater than 1. In some embodiments, the VBOOST_ENline is only enabled to turn on the voltage up-converter 370 during thestimulation pulse. Between consecutive stimulation pulses, the VBOOST_ENline is disabled to turn off the voltage up-converter 370. In thismanner, power consumption is reduced, since the voltage up-converter isnot running all the time. The microcontroller 400 further includes anInput/Output (I/O) bus, a Serial-Peripheral-Interface (SPI)communication bus, and an Inter-Integrated-Circuit (I²C) communicationbus, which allow the microcontroller 400 to communicate with peripheralsor external devices.

Another peripheral-like device of the microcontroller 400 is a timerunit 425. The timer unit 425 includes hardware and firmware/softwarethat control the timing for turning on and off the microcontroller core410 and/or enabling/disabling the peripherals or other components of thePNS device 200. Although not illustrated herein for reasons ofsimplicity, the microcontroller 400 may also include one or moreinternal clocks. These internal clocks serve as timing sources for thetimer unit 425.

In addition, a crystal oscillator 430 is external to the microcontroller400 and is coupled to the microcontroller 400. In some embodiments, thecrystal oscillator 430 generates a 32.678 Khz clock that may be usedwhen the microcontroller 400 enters a power-conservation operating mode(also referred to as a low-power mode or a sleep mode) to reduce powerconsumption. The crystal oscillator 430 may also serve as a timingsource for the timer unit 425.

In addition to the microcontroller 400, the stimulation circuitry 305further includes a plurality of sensors that are electrically orcommunicatively coupled to the microcontroller 400. In the illustratedembodiment shown in FIG. 7, a magnetic sensor 435 is coupled to themicrocontroller 400 through the I/O bus, and a temperature sensor 440and an accelerometer 445 are each coupled to the microcontroller 400through the I²C communication bus. In some embodiments, the magneticsensor 435 may be used to turn on or off the PNS device 200, thetemperature sensor 440 may be used to facilitate the energy harvested bythe energy harvesting component 350, and the accelerometer 445 may beused to detect a posture of the patient, which may then be used toperform posture-dependent calibration. It is understood that thesesensors 435-445 are merely examples, and that additional sensors such aspressure sensors, humidity sensors, vibration sensors, proximitysensors, light sensors, strain/stress sensors, transducers, gyroscopes,or compasses may be implemented in the PNS device 200 in variousembodiments.

The stimulation circuitry section 305 further includes a stimulationdriver 450 coupled to the DAC output of the microcontroller 400. Thestimulation driver 450 includes amplification circuitry (e.g., op-amps)that is capable of amplifying an amplitude of the stimulation pulsesgenerated by the DAC of the microcontroller 400. For example, in someembodiments, the stimulation driver 450 can amplify the amplitude of thestimulation pulses by a factor of 5. The amplification (or scaling up)of the variation stimulation waveforms (i.e., the stimulation pulsesoutputted by the DAC) obviates the need for a custom DAC.

The stimulation circuitry section 305 also includes stimulationmultiplexers 460 that are coupled to the stimulation driver 450. Themultiplexed stimulation outputs allow for configured stimulation contactcombinations. In more detail, the stimulation multiplexers 460 serve asan array (e.g., 16 for anodes and 16 for cathodes) of switches thatcoupled to a plurality of stimulation channels through DC-blockingcapacitors 465, respectively. The switches are coupled in parallel toone another. Through the turning on and off of these switches,electrical stimulation pulses can be delivered to the desiredstimulation channel(s).

To help conserve energy, the stimulation driver 450 and the stimulationmultiplexers are powered by either the battery 340 directly, or by thevoltage output produced by the voltage up-converter 370, but not both.For example, when the stimulation pulse amplitude is less than what thebattery 340 is capable of providing (e.g., stimulation voltage is at 3volts, and the battery 340 outputs 4 volts), the voltage up-converter370 need not be turned on, because the voltage up-converter 370 wouldconsume power when it is turned on. The voltage up-converter 370 isturned on when the stimulation pulse demands a greater amplitude thanthe battery 340 is capable of providing. In this manner, the voltageup-converter 370 is selectively turned on or off to minimize powerconsumption. Thus, the output of the voltage up-converter 370 serves asthe power supply for the stimulation driver 450 and the stimulationmultiplexers 460 when needed, and the battery 340 serves as the powersupply the rest of the time.

To ensure such operation, the present disclosure implements a diode 470coupled between the output of the battery 340 and the inputs of thestimulation driver 450 and the stimulation multiplexers 460. Anotherdiode 475 is also implemented between the output of the voltageup-converter 370 and the inputs of the stimulation driver 450 and thestimulation multiplexer 460. These two diodes 470 and 475 are coupled inparallel with each other and serve as switches such that only one pathis created between the power source (either the battery 340 or thevoltage up-converter 370) and the stimulation driver 450 and thestimulation multiplexer 460. When the voltage up-converter 370 is turnedon, the diode 475 is forward-biased to create a charging path from thevoltage up-converter 370 and the stimulation driver 450 and thestimulation multiplexers 460, while the diode 470 is reverse-biased toblock the path from the battery 340 to the stimulation driver 450 andthe stimulation multiplexers 460. This also ensures that the voltageup-converter 370 will not inadvertently charge the battery 340. When thevoltage up-converter 370 is turned off, the diode 470 is forward-biasedto create a charging path from the battery 340 and the stimulationdriver 450 and the stimulation multiplexers 460, while the diode 475 isreverse-biased to block the path from the voltage up-converter 370 tothe stimulation driver 450 and the stimulation multiplexers 460.

The stimulation circuitry section 305 further includes a switch 480 thatis coupled between the output of the voltage up-converter 370 and theinputs of the stimulation driver 450 and the stimulation multiplexers460. The switch 480 is also coupled to the microcontroller 400. Inresponse to instructions from the microcontroller 400, this switch 480may disconnect any load (e.g., the stimulation driver 450 and thestimulation multiplexers 460) from the voltage up-converter 370 betweenconsecutive stimulation pulses, thereby preserving energy stored in thevoltage up-converter 370 for the next stimulation pulse.

The stimulation circuitry section 305 may also include a sense amplifier490 coupled between the output of the stimulation multiplexers and themicrocontroller 400. In certain embodiments, the sense amplifier 490 isconfigured to sense action potentials of a target nerve. The sensedaction potentials are fed back to the microcontroller for furtherprocessing and analysis. In some embodiments, the sense amplifier 490can also measure impedance values.

The telemetry circuitry section 310 includes a telemetry block 500. Thetelemetry block 500 is powered by the voltage down-converter 360. Thetelemetry block 500 is also electrically and communicatively coupled tothe microcontroller 400. The telemetry block 500 includes one or moretransmitters, receivers, and/or transceiver. For example, the telemetryblock 500 may include one or more of the following: a Medical ImplantCommunication Services (MICS) transceiver, an Industrial, Scientific andMedical (ISM) transceiver, a Wi-Fi transceiver, a Bluetooth transceiver,DLNA, or any of the 3G or 4G cellular networking transceivers. Throughthe telemetry block 500, the PNS device 200 may conduct bi-directionaltelecommunications with external devices, for example turning on/off thePNS device 200, receiving commands or programming instructions from theelectronic programmer 250 discussed above, or transfer diagnostic dataor unique patient information to the electronic programmer 250 or to aremote server.

The telemetry circuitry section 310 further includes an antenna 510 fortransmitting and receiving telemetry signals. In some embodiments, theantenna 510 and the inductive charging component 320 may be the samecomponent. In other words, a single conductive component such as a loopcoil or wire may be used to charge the PNS device 200 and to conducttelecommunications with the PNS device 200.

For example, the antenna 510 may receive telemetry signals that are indifferent radio bands, such as signals in a MICS band (between 402 Mhzand 405 Mhz, which may hereinafter be referred to as a 400 Mhz MICSband) and signals in a 2.45 Ghz ISM band (between 2.4 Ghz and 2.5 Ghz).The telemetry signals in the 2.45 Ghz band may be used to “wake up” thePNS device 200, which is normally in a deep “sleep” mode, where littlepower is being consumed. After the PNS device 200 is “woken up,” thetelemetry signals in the MICS band are used to conducttelecommunications between the PNS device 200 and external devices suchas the electronic programmer 250. Since the PNS device 200 employs asingle antenna 510 to receive multiple types of telemetry signals, thesedifferent types of telemetry signals need to be properly discriminated,otherwise one type of telemetry signals may cause interference or createnoise for the other type of telemetry signals.

According to the various aspects of the present disclosure, thetelemetry circuitry section 310 includes a plurality of circuits orcircuit networks to discriminate different types of input signalsreceived from the antenna 510. In the illustrated embodiment, circuitnetworks 520 and 530 are implemented in the telemetry circuitry section310. The circuit network 520 includes microelectronic components thatwill allow the telemetry signals in the MICS radio band to pass throughbut will reject signals outside the MICS radio band, including thetelemetry signals in other bands (e.g., telemetry signals in the 2.45Ghz band) and charging signals (e.g., charging signals in the 13.56 MhzISM band). The circuit network 530 includes microelectronic componentsthat will allow the telemetry signals in the 2.45 Ghz radio band to passthrough but will reject signals outside the 2.45 Ghz radio band,including the telemetry signals in other bands (e.g., telemetry signalsin the 400 Mhz MICS band) and charging signals (e.g., charging signalsin the 13.56 Mhz ISM band). In this manner, the circuit networks 520 and530 provide discrimination for the input signals.

It is understood that although the circuit network 325 is not a part ofthe telemetry circuitry section 310, it also helps providediscrimination of the input signals. As discussed above, the antenna 510and the inductive charging component 320 may be the same conductivecomponent, for example, a single turn wire or coil. In other words, thesame wire or coil may be used to receive both charging signals (e.g.,inductive energy in the 13.56 Mhz ISM band) and telemetry signals in the400 Mhz MICS band and telemetry signals in the 2.45 Ghz band. Thus, thecircuit network 530 includes microelectronic components that will allowthe charging signals in the 13.56 Mhz ISM band to pass through but willreject signals outside the 13.56 Mhz ISM band, including the telemetrysignals in the 400 Mhz MICS band and in the 2.45 Ghz ISM band.

The circuit networks 520 and 530 may also each include passivecomponents such as inductors and capacitors for impedance matching.Impedance matching may maximize power transfer or may reduce signalreflection (for example, reflection from a load). In the illustratedembodiment, the circuit networks 520 may include passive circuitelements collectively arranged to match the impedances of the telemetryblock 500 and the antenna 510 in the 400 Mhz MICS band. In someembodiments, the circuit network 530 may also include passive circuitelements collectively arranged to match the impedances of the telemetryblock 500 and the antenna 510 in the 2.45 Ghz frequency band.

FIGS. 8A-8L are detailed circuit schematics of the PNS device 200according to an embodiment of the present disclosure. However, it isunderstood that the PNS device 200 may be implemented differently inalternative embodiments and is not limited to the specificimplementation shown in FIGS. 8A-8L.

Paddle Lead Maximizing Lateral Target Points Across a Peripheral Nerve

As discussed above, unlike spinal cord stimulation devices, the PNSdevice 200 is specifically configured to deliver electrical stimulationfor peripheral nerves. Referring to FIG. 9, peripheral nerves comprise‘bundles’ (e.g., bundles 570) of groupings of axons called fascicles.Typically, a fascicle innervates a particular area or region of thebody. Additionally, some fascicles carry a predominance of efferentmotor fibers while others carry mostly afferent sensory fibers.

Depending upon the therapeutic application at hand, peripheral nervestimulation systems typically seek to activate only motor nerves (e.g.,for functional purposes, such as dorsiflexion for a dropped foot, or agrasp for upper extremity hemiplegia), or only sensory nerves (e.g., forneuropathic pain management). In any particular application, neuralselectivity is usually achieved by maximally activating the targetedfascicles while avoiding activation of those fascicles that may lead toside effects (e.g., in pain management, stimulation of motor nerves canlimit the efficacy of the therapy that is to be provided).

One method of peripheral nerve stimulation uses paddle leads, asimplified example of which is shown as a lead 580 in FIG. 9. Concertedeffort is required to place paddles at least near or over the targetedfascicles, but this can usually be achieved intraoperatively in anominal amount of time.

One challenge with paddle leads in peripheral nerve stimulation is theneed to provide contacts or electrodes in the paddle lead that are of acertain size or surface area so that charge density concerns can bemanaged, which include avoiding the creation of toxic electrochemicalproducts generated by stimulation currents at the contact or electrodelocation, or associated with contact corrosion. Typical paddleelectrodes or contacts are rectangular with a nominal surface area. Thecontact width necessary to maintain current flow below charge densitylimits is such that the ability to provide fine fascicular targetingbecomes limited, in part because contacts can only be placed on a paddlelead such that they do not electrically short together duringmanufacture or implantation. What is needed includes a paddle leadconfigured to maximize transverse fascicular targeting or selectivity ina peripheral nerve, or a paddle lead that permits fine separation offascicles in a targeted nerve.

Referring now to FIG. 10, a simplified diagrammatic view of an exampleimplantable lead 600A of the present disclosure is illustrated accordingto an embodiment. The implantable lead is configured to be coupled orattached to the PNS device 200 discussed above. The implantable lead600A delivers electrical stimulation pulses generated by the stimulationcircuitry 305 of the PNS device 200 to target peripheral nerves. Theimplantable lead 600A includes an elongate flexible/bendable lead body610 that includes a coupling assembly (not specifically illustratedherein), which is configured to be coupled to the PNS device 200. Theimplantable lead 600A also includes a paddle 620A that includes aplurality of electrodes (also referred to as contacts), for exampleelectrodes 1-8 as shown in FIG. 10. Electrical stimulation pulses aredelivered to the target peripheral nerve through these electrodes.

According to various aspects of the present disclosure, the electrodes1-8 are collectively arranged in a manner such that they provide aplurality of unique centerlines 631-638. For example, the paddle lead600A includes a plurality of rows of electrodes oriented along itslength such that the respective centerline of the electrode(s) on eachrow is mostly or completely different from those on other rows. In theillustrated embodiment, the centerlines 631-638 extend in an X-directionor along an X-axis, whereas the fascicles of the target peripheral nervetypically extend in a Y-direction or along a Y-axis (perpendicular tothe X-axis). In general, it is desired to try to keep the centerlines ofthe electrodes in the middle of the targeted nerves, as it offersredundancy and flexibility to recover/restore stimulation inspite ofslight movements of the nerve or electrode.

Most conventional paddle leads typically employ a grid approach for itselectrodes, where the electrodes are neatly arranged into rows andcolumns, and where all the electrodes in the same row are aligned withone another (e.g., aligned along the X-axis), and all the electrodes inthe same column are aligned with one another (e.g., aligned along theY-axis). Consequently, conventional paddle leads can only offer a verylimited number of unique centerlines. For example, a conventional paddlelead with 9 electrodes with a 3×3 configuration can only offer 3 uniquecenterlines. As discussed above, the centerlines are correlated with theassociated electrode's ability to provide target stimulation. Thus,having a limited number of centerlines may prevent the PNS device fromproviding flexible stimulation therapies.

In comparison, the paddle 620A has a 3-2-3, 8-contact or electrodeconfiguration in the embodiment illustrated in FIG. 10. As is shown inFIG. 10, the 8 electrodes are arranged to achieve 7 unique centerlines(electrodes 2 and 7 have substantially the same centerline) transverselydisposed across the nerve over which it is placed. In other words, asubstantial majority (7 out of 8) of the electrodes on the paddle 620Ahave their own respective unique centerlines. Alternatively stated, theelectrodes 1-8 on the paddle 620 are “staggered.” Such staggered 3-2-3electrode arrangement of the paddle lead 600A permits fine separationsof fascicles (or allows for greater fascicular selectivity) in a nerveto be targeted, because individual electrodes can be activated ascathodes on different rows to ‘sweep’ the stimulation field across thenerve to find the location that maximizes the desired therapeutic effectwhile minimizing side effects. In some embodiments, the electrodes631-638 of the paddle lead 600A are configured to take into account thetendency of fascicles in peripheral nerves to run in a relatively fixedlongitudinal course along the length of the nerve that is to bestimulated.

In addition, since the paddle lead 600A is configured for peripheralneural stimulation, the spacing between adjacent electrodes may be smalltoo. In some embodiments, a distance 650 separating adjacent electrodesin the X-direction is in a range from about 1 millimeters (mm) to about5 mm, and a distance 655 separating adjacent electrodes in theY-direction is in a range from about 2 millimeters (mm) to about 5 mm.The distance 650 may also be referred to as a horizontal spacing, andthe distance 655 may also be referred to as a vertical spacing.

These distances 650-655 are significantly smaller than the distancesseparating adjacent electrodes on a paddle lead configured to deliverspinal cord stimulation. This is because in the context of spinal cordstimulation, the paddle would be implanted near the spinal cord, whichmay span a great distance. Thus, the paddle lead for spinal cordstimulation is typically configured to have electrodes that are spacedfarther apart, so that they can span a relatively long distance that maybe required to reach the target stimulation site. It is not as importantto achieve such fine resolution in the spinal cord stimulation context.

In comparison, peripheral nerve stimulation is typically focused in arelatively small area. In addition, as discussed above, peripheral nervestimulators need to achieve high neural selectivity in the target nervesuch that only the desired nerve fibers (for example, only the efferentfibers or only the afferent fibers) are activated but not the other. Assuch, peripheral nerve stimulators need to have smaller distancesseparating adjacent electrodes to allow for the high neural selectivity.

It is understood that the electrodes 631-638 may be substantially evenlyor uniformly spaced apart in either the X-direction or the Y-direction(or both) in some embodiments, or they may be unevenly spaced apart inthe X or Y-directions in other embodiments.

FIG. 11 illustrates a simplified diagrammatic view of an implantablelead 600B according to another embodiment of the present disclosure. Theimplantable 600B has a paddle 620B that is similar to the paddle 620Ashown in FIG. 10. However, the electrodes 1-8 of the paddle 620B arearranged such that every electrode has a unique respective centerlinethat extends in the X-direction. In other words, the paddle 620Bachieves a total of 8 unique centerlines with 8 electrodes, compared tothe 7 centerlines achieved by the paddle 620A in FIG. 10.

In some embodiments, electrodes are not arranged in a grid per se, butare offset from one row to the next. In some embodiments, none of theelectrodes in a single row on the paddle are arranged in a singlecolumn. For example, referring now to FIG. 12, a simplified diagrammaticview of an implantable lead 600C is illustrated according to anotherembodiment of the present disclosure. The implantable 600C has a paddle620C that contains electrodes 1-9. The electrodes 1-9 are arranged in astaggered manner in both the X-direction and the Y-direction. In moredetail, the electrodes 1-9 are roughly arranged into 3 “columns” 660,661, and 662, and 3 “rows” 665, 666, and 667. The column 660 includeselectrodes 1-3, the column 661 includes electrodes 4-6, and the column662 includes electrodes 7-9. The row 665 includes electrodes 1, 4, and7, the row 666 includes electrodes 2, 5, and 8, and the row 667 includeselectrodes 3, 6, and 9.

However, the electrodes in each column are not aligned in theY-direction, and the electrodes in each row are not aligned in theX-direction. Rather, the electrodes in each column are still offset fromone another, as are the electrodes in each row. For example, the columns660-662 may each extend in a direction 668 that is somewhat “vertical”but is not parallel to the X-axis or the Y-axis. In other words, thedirection 668 has a greater Y-component than an X-component. The rows665-667 may each extend in a direction 669 that is somewhat “horizontal”but is also not parallel to the X-axis or the Y-axis. In other words,the direction 669 has a greater X-component than a Y-component.

Since the directions in which the columns and rows extend are notparallel with the X or Y axes, the electrodes 1-9 offer unique verticaland horizontal centerlines. According to the embodiment of the paddle620C shown in FIG. 12, the electrodes 1-9 have horizontal centerlines(i.e., centerlines spanning in the X-direction) 631-639, and theelectrodes 1-9 have vertical centerlines (i.e., centerlines spanning inthe Y-direction) 671-679. The electrodes 1-9 are staggered horizontallyand vertically such that they collectively offer 9 unique horizontalcenterlines 631-639, as well as 9 unique vertical centerlines 671-679.

As discussed above, having the plurality of unique horizontal andvertical centerlines 631-639 and 671-679 affords the paddle 620C theflexibility and versatility to selectively stimulate one or more targetnerve fibers but not the undesired nerve fibers, even if the desired andundesired nerve fibers are closely located to one another. In otherwords, the staggered electrode arrangement discussed herein can achievehigh neural selectivity, and the PNS system with the implantable lead600C permits very precise spatial targeting of different portions of anerve.

FIG. 13 illustrates a simplified diagrammatic view of an implantablelead 600D according to yet another embodiment of the present disclosure.The implantable lead 600D is similar to the implantable lead 600C shownin FIG. 12 in that it also offers an electrode arrangement that is bothhorizontally staggered and vertically staggered. However, the electrodes1-9 on the paddle 620D are even more staggered. For example, thehorizontal and vertical distances separating adjacent electrodes may beuneven or non-uniform. As another example, there may not be any lineardirection in which any of the “columns” 660-662 or the “rows” 665-667extend, let alone a direction that is parallel to either the X-axis orthe Y-axis. In some embodiments, even if some of the “columns” or “rows”extend along a particular linear direction, such linear direction wouldnot be parallel with any linear direction of any other “column” or“row.” Stated differently, none of the “columns” 660-662 is parallelwith any other of the columns on the paddle 620D, and none of the “rows”665-667 is parallel with any other of the rows on the paddle 620D. Thehorizontal centerlines 631-639 are still each unique, as are thevertical centerlines 670-679. Again, such staggered electrodearrangement may permit good neural selectivity.

FIG. 14 illustrates a simplified diagrammatic view of an implantablelead 600E according to yet another embodiment of the present disclosure.Here, the implantable lead 600E includes a paddle 620E that has 12electrodes implemented thereon. The 12 electrodes are collectivelyarranged in roughly 3 “columns” and 4 “rows” and collectively define astimulation region 680 on the paddle 620E. The boundaries or outlines ofstimulation region 680 may be defined by a topmost edge of a topmostelectrode (electrode 1 in this case), a bottommost edge of a bottommostelectrode (electrode 12 in this case), a leftmost edge of a leftmostelectrode (electrode 4 in this case), and a rightmost edge of arightmost electrode (electrode 9 in this case). As such, the stimulationregion 680 has approximately a rectangular shape. However, it isunderstood that the outlines or boundaries of the stimulation region 680may not be actually visible on the paddle 620E.

The electrodes 1-12 are staggered to the extent such that no horizontallinear paths (or a straight line parallel to the X-axis) or verticallinear paths (or a straight line parallel to the Y-axis) across thestimulation region 680 may exist without intersecting at least one ofthe electrodes 1-12. Stated differently, within the stimulation region680, every horizontal linear path and every vertical linear path willintersect at least one of the electrodes 1-12. This is due to thepartial overlap in both the X-and-Y-directions among the electrodes1-12. For example, electrodes 1 and 5 are overlapped in the Y-direction,as are electrodes 5 and 9, as are electrodes 9 and 2, as are electrodes2 and 6, so on and so forth. Similarly, electrodes 4 and 3 areoverlapped in the X-direction, as are electrodes 3 and 2, as areelectrodes 2 and 1, as are electrodes 1 and 8, so on and so forth.Therefore, if a horizontal or vertical linear path is to extend acrossthe entire stimulation region 680, one or more of the electrodes 1-12will necessarily be in its path. It may be said that the staggeredelectrode arrangement of the paddle 620E completely blocks allhorizontal and linear paths across the stimulation region 680. As such,the staggered electrode arrangement of the paddle 680 may theoreticallypermit electrical stimulation in almost every target nerve site coveredby the stimulation region 680, thereby imparting a high degree ofadjustability and targetability of delivered electrical stimulus.

It is understood that in some embodiments, such as the embodiment of thepaddle 620C shown in FIG. 12, there may be some horizontal or verticallinear paths that may extend across the entire stimulation region 680without intersecting at least one of the electrodes. However, even insuch embodiments, a substantial majority (e.g., greater than 70%, 80%,or 90% in various implementations) of the available horizontal andvertical linear paths may still intersect with at least one electrode,because there is still some amount of horizontal or vertical overlapamong the electrodes 1-9 on the paddle 620C. Therefore, it may be saidthat in these embodiments (e.g., embodiment shown in FIG. 12), thestaggered electrode arrangement blocks a substantial majority of thehorizontal and linear paths across the stimulation region. Even in theseembodiments, however, the amount of overlap (in the X or Y directions)among the electrodes may still offer a high degree of adjustability andtargetability of delivered electrical stimulus.

In each of the embodiments of the paddle lead 600 shown in FIGS. 10-14and discussed above, there are at least 3 “rows” and/or 3 “columns” ofelectrodes. In other embodiments, any other number of columns or rowsgreater than 3 may be implemented for the paddle with staggeredelectrodes. The greater number of rows or columns allows the paddle tobe better suited for peripheral nerve stimulation, as the peripheralnerves may have irregular shapes and may span in various directions. Incomparison, many conventional paddle leads only have 1 or 2 columns ofelectrodes. This is adequate for spinal cord stimulation, since thetarget nerves in the SCS context extend along the spine, which is mostlystraight and narrow. However, these SCS paddle leads with 1 or 2 columnsof electrodes will not work very well in the peripheral nervestimulation context, since the 1 or 2 columns of electrodes may not beable to reach all the target stimulation areas, and maintain targetedstimulation over desired regions, due to the geometric differencesbetween the spinal cord and the peripheral nerves, primarily thetortuous winding nature of peripheral nerves within their neurovascularbundles. For these reasons, the various embodiments of the implantablelead 600 discussed herein are specifically configured to have 3 or morecolumns or rows of electrodes, which are also arranged in a staggeredformation, in order to provide better a peripheral stimulation therapy.Further, the staggered electrode arrangements shown in FIGS. 10-14 allowfor formations of a plurality of different “stimulation paths” betweenthe various electrodes on the lead. These “stimulation paths” betweenthe electrodes extend in a variety of directions due to the electrodesbeing staggered, whereas the conventional neatly-arranged rows andcolumns of electrodes may allow for much fewer “stimulation paths” thatextend in different direction. Also due to the staggered electrodesherein, various “stimulation paths” may be created to generate electricfields that can be flexibly shaped. Therefore, the ability of the paddlelead herein to establish these “stimulation paths” allows for moreversatile and flexible stimulation zones and steering of stimulationover small and larger target regions, which as discussed above is aunique concern of peripheral stimulation that does not exist in thespinal cord stimulation context.

Circuit for Discriminating Between Battery Charging Signals and RFTelemetry Signals Received by a Single Coil in an Implantable MedicalDevice

As discussed above, another one of the unique aspects of the presentdisclosure is that it utilizes a single conductive element (e.g., coil)to receive different types of charging and telemetry signals andutilizes various circuit elements to provide discrimination for thesedifferent types of signals. This aspect of the present disclosure is nowdiscussed in greater detail below.

FIGS. 15A-15C provide various illustrations of a coil 700 that is anembodiment of the inductive charging component 320 and the antenna 510shown in the block diagram of FIG. 7. In other words, the coil 700 canbe used to receive both inductive charging signals (e.g., at the 13.56Mhz ISM band) and telemetry signals (e.g., at the 400 Mhz MICS band andat the 2.45 Ghz ISM band). In more detail, FIG. 15A illustrates thedisposition of the coil 700 in an embodiment of the PNS device 200, FIG.15B illustrates the coil 700 by itself, and FIG. 15C shows top views ofa few different embodiments of the coil as coil 700A, 700B, and 700C.

The coil 700 shown in FIGS. 15A and 15B in FIG. 15C are each a singleturn piece of wire having an approximately rectangular shape withrounded corners. The embodiment of the coil 700B shown in FIG. 15Cincludes an inside turn and an outside turn and thus has a slightlydifferent Q factor, inductance, and resistance compared to the singleturn embodiment of the coil 700A. The embodiment of the coil 700C shownin FIG. 15C includes two side-by-side turns and thus also has a slightlydifferent Q factor, inductance, and resistance compared to the singleturn embodiment of the coil 700A or compared to the inside/outside turnembodiment of the coil 700B. As shown in FIG. 15A, the coil 700 isimplemented outside of a hermetically-sealed housing or enclosure (alsoreferred to as a can) 710 of the PNS device 200. Most of the circuitrydiscussed above with reference to FIG. 7 are implemented within thehermetically-sealed housing 710, including but not limited to, thebattery 340, the voltage down-converter 360 and the voltage up-converter370, the microcontroller 400, the sensors 435-445, the stimulationdriver 450, the stimulation multiplexers 460, the telemetry chip 500,the circuit networks 325, 520, 530, etc.

It is understood that in these embodiments, the coil 700 is optimized toreceive signals at the 13.56 Mhz band, the 400 Mhz band, and the 2.45Ghz band, since these bands are employed to carry out the inductivecharging and telecommunications of the present embodiment of the PNSdevice 200. However, in alternative embodiments where the PNS device mayutilize different frequency bands to conduct charging andtelecommunications, the coil may be optimized differently for thosebands as well.

Conventionally, neurostimulators use an antenna to receive telemetrysignals and a separate charging coil to receive inductive chargingsignals. The antenna is typically located outside a hermetically-sealedhousing (e.g., made of metal or a metal alloy) for the pulse generator,which contains most of the circuitry such as charging circuitry,stimulation circuitry, and telemetry circuitry. The placement of theantenna outside the housing is for better signal reception. The chargingcoil is typically located inside the hermetically-sealed housing becausetraditional charging signals are limited at very low frequencies (e.g.,40 Khz-80 Khz), which can penetrate through metal relatively easily.However, the low charging frequencies are associated with a lowerquality factor (Q), which leads to charging inefficiencies. The lowcharging frequencies also require the charging coil to have many turns(e.g., 50 turns or more), which consumes a lot of space. In other words,the implementation of a signal antenna outside the housing and aseparate charging coil inside the housing results in bigger, morecumbersome neurostimulation device that may have inadequate chargingperformance.

In comparison, a single conductive element such as the coil 700 is usedto receive both telemetry signals and charging signals. The coil 700 andthe corresponding circuitry inside the PNS device 200 are configured toreceive charging signals at a much higher frequency (e.g., 13.56 Mhz)than the low charging frequencies for conventional neurostimulators. Assuch, the coil 700 can have a much higher Q than the charging coils forconventional neurostimulators. The higher Q results in better chargingefficiency and quicker charging time. In addition, since the chargingfrequency is higher, a single turn is sufficient for the coil 700, andit can be implemented outside the hermetically-sealed housing.Furthermore, the implementation of the coil 700 outside the housingreduces heating effects, and it may allow less expensive materials to beused for the housing. In some embodiments, MRI compatibility can also beenhanced, for instance, by providing no ferrite core. The material usedfor the single-turn coil 700 may also result in low resistance. The sizeof the coil 700 (e.g., due to using only a single turn wire) can also bemuch smaller than the charging coil for conventional neurostimulators.

For these reasons discussed above, the design of using a single coil forboth telemetry and charging allows the PNS device 200 to be made small,cheap, and have improved performance over conventional neurostimulators.However, since a single coil 700 is used for both telemetry andcharging, the PNS device 200 needs to be able to discriminate thetelemetry and charging signals, so that they do not cause interferencefor one another, as discussed below.

FIG. 16 is a simplified block diagram of the various components anddevices of the PNS device 200 that provide signal discrimination for thedifferent types of signals received by a single antenna. Again, it isunderstood that in the illustrated embodiment, the inductive chargingcomponent 320 and the antenna 510 shown in the block diagram of FIG. 7are integrated together as a single coil 700. The coil 700 iselectrically coupled to the circuit networks 320, 520, and 530, each ofwhich is discussed above with reference to FIG. 7. It can be seen thatthe circuit networks 320, 520, and 530 are electrically coupled inparallel. As such, the networks 320, 520, and 530 provide parallelsignal paths for different types of signals.

The circuit network 320 is coupled to the charging circuit 330 (alsodiscussed above with reference to FIG. 7) and allows inductive chargingsignals at the 13.56 Mhz band to pass through to the charging circuit330 by way of resonant network elements. In some embodiments, thecircuit network 320 includes a resonant network that generates a high Qat the resonant frequency, where the resonant frequency is tuned to besubstantially equal to the frequency of the charging signal (e.g., at13.56 Mhz). As such, the reception of signals is maximized at thecharging frequency, thereby allowing the charging signal to pass throughwith minimal attenuation. Meanwhile, although the resonant network isnot specifically configured to filter out signals from the 400 Mhz orthe 2.45 Ghz bands, the reception of the signals outside the resonantfrequency is not maximized due to the resonant frequency being at orsubstantially near the 13.56 Mhz. Thus, the resonant network of thecircuit network 320 may effectively function as a very narrow band-passfilter to “block” signals that are outside of the 13.56 Mhz band. Assuch, to the extent that the 400 Mhz and the 2.45 Ghz telemetry signalsare received by the network 320, they will be substantially attenuatedby the time they reach the charging circuit 330.

Meanwhile, the circuit networks 520 and 530 are each coupled to atelemetry chip 500 that is an embodiment of the telemetry block 500(also discussed above with reference to FIG. 7). Using filters such as aband-pass filter and a high-pass filter, the circuit network 520 allowstelemetry signals at the 400 Mhz MICS band to pass through to thetelemetry chip 500, but blocks out telemetry signals at other frequencybands (e.g., signals at the 2.45 Ghz ISM band) and inductive chargingsignals (e.g., signals at the 13.56 Mhz band). Similarly, using filterssuch as a high-pass filter, the circuit network 530 allows telemetrysignals at the 2.45 Ghz ISM band to pass through to the telemetry chip500, but blocks out telemetry signals at other frequency bands (e.g.,signals at the 400 Mhz MICS band) and inductive charging signals (e.g.,signals at the 13.56 Mhz band). Additionally, the circuit network 520and/or the circuit network 530 may include additional passive circuitelements such as inductors and/or capacitors for impedance matching, soas to maximize power transfer or to reduce signal reflection, etc. Thefiltering out of the undesired signals will minimize the interferencethat these undesired signals may cause to the desired signals.

Again, it is understood that the frequency bands used herein are merelyexamples. In other embodiments, the same approach shown in FIG. 16 maybe used to provide discrimination of other types of inductive chargingsignals and telemetry signals that may be collectively received by thesame antenna or coil. It is also understood that in a real worldimplementation, it may not be possible to completely block or filter outsignals from an undesired frequency band. Thus, in the context of thepresent disclosure, “signal blocking”, “signal filtering”, or othersimilar phrases may mean that the undesired signals are substantiallyattenuated to the point where they no longer cause any meaningfulinterference. In other words, even if some portions of the undesiredsignals may get through one of the circuit networks 320, 520, and 530discussed above, they may be negligible because their amplitudes aresufficiently small. In various embodiments, the circuit networks 320,520, and 530 may provide signal attenuations anywhere from about 10 dBto about 100 dB, for example from about 20 dB to about 60 dB.

FIG. 17 includes detailed circuit schematics of an embodiment for eachof the circuit networks 320, 520, and 530 discussed above. These circuitschematics are extracted from the circuit schematic of the PNS device200 shown in FIG. 8. In addition, to provide more clarity, simplifiedblock diagrams of the charging circuit 330 and the telemetry chip 500are appended next to the circuit schematics of the corresponding circuitnetworks 320, 520, and 530. It is also understood that a circuit node“ANT+” represents the signal line to the single antenna (or the coil 700shown in FIG. 16)

According to the embodiment shown in FIG. 17, the circuit network 320includes a series-resonant capacitor C42 and/or a parallel-resonantcapacitor 46. These resonant capacitors C42 and C46 are tuned such thatthey have a narrow resonant frequency at around 13.56 Mhz (since 13.56Mhz is the band of the inductive charging signals in this case). Asdiscussed above, the resonant capacitors C42 and C46 in effect serve asa narrow band-pass-like filter, where the pass-band is centered around13.56 Mhz. As such, the inductive charging signals of the 13.56 Mhz ISMband are able to pass through, whereas signals from other frequencybands end up being “rejected” because they are outside the resonantfrequency. In some embodiments, the series capacitor C42 may be removed,and only the parallel-resonant capacitor C46 is used to provide aresonant frequency.

The circuit network 320 further includes a diode D5 that is electricallycoupled to the capacitor C42. The diode D5 serves as a rectifyingelement. In other words, the diode D5 converts the AC inductive signalthat passes through (13.56 Mhz) into a DC signal. In other embodiments,alternative types of DC rectifiers may be used instead. The circuitnetwork 320 also includes a capacitor C43, which serves as an energystorage element herein. The inductor L5 may serve as an inductor for thebooster circuit, and the capacitor C44 may serve as a referencecapacitor for the booster circuit.

The circuit network 520 includes a band-pass filter FL1, whose pass-bandin this embodiment is centered around the 400 Mhz MICS band. Forexample, the pass-band of the band-pass filter FL1 may be fromapproximately 402 Mhz to about 405 Mhz. As such, the desired telemetrysignals in the MICS band will pass through the circuit network 520,whereas inductive charging signals and telemetry signals from otherbands will be substantially rejected. In order to provide furtherattenuation for undesired signals, the circuit network 520 also includesa high-pass filter that is formed by an inductor L2 and capacitors C1and C2. This high-pass filter is specifically targeted at the inductivecharging signals, for example signals at the 13.56 Mhz band, since theseinductive charging signals may be high in amplitude and thus warrantsfurther attenuation.

In addition, the circuit network 520 also includes passive circuitelements L1, C9, C3, and C7 that are collectively configured to optimizeimpedance matching between the antenna (coil 700) and the telemetry chip500. Again, the impedance matching provided by the passive circuitelements L1, C9, C3, and C7 may maximize power transfer (e.g., from theantenna to the telemetry chip 500 or vice versa) and/or reduce signalreflection.

The circuit network 530 includes a high-pass filter formed by aninductor L3 and capacitors C11 and C12. This high-pass filter isconfigured such that the inductive charging signals in the 13.56 Mhzband and the telemetry signals in the 400 Mhz MICS band will besubstantially rejected, but the telemetry signals in the 2.45 Ghz band(e.g., used to wake up the PNS device 200) will be allowed to passthrough.

Again, it is understood that the specific implementation of the circuitnetworks 320, 520, and 530 shown in FIG. 17 is merely an exampleimplementation. In alternative embodiments, the specific values may bechanged for the resistors, the inductors, and the capacitors shown inFIG. 17. The circuit networks 320, 520, and 530 may also includeadditional circuit elements, or some of the circuit elements may beeliminated without departing from the spirit and scope of the presentdisclosure. Furthermore, in some embodiments, digital-signal-processor(DSP) chips or other chips with advanced firmware/software may be usedto replace one or more of the circuit networks 320, 520, and 530discussed above.

FIG. 18 is a simplified flowchart of a method 800 of providingdiscrimination for a plurality of types of input signals received from asingle antenna according to an embodiment of the present disclosure. Themethod 800 includes a step 810 of receiving, via the single antenna,inductive charging signals and first telemetry signals. The inductivecharging signals are in a first frequency band, the first telemetrysignals are in a second frequency band that is substantially higher thanthe first frequency band.

The method 800 includes a step 820 of generating, via a first circuitcoupled to the single antenna, a resonant frequency substantially nearthe first frequency band such that the first circuit allows theinductive charging signals to pass through while attenuating the firsttelemetry signals.

The method 800 includes a step 830 of rejecting, via a second circuitcoupled to the single antenna, the inductive charging signals whileallowing the first telemetry signals to pass through.

In some embodiments, the first and second circuits are integrated withina hermetically-sealed housing of a peripheral nerve stimulation (PNS)device. The single antenna is located outside the hermetically-sealedhousing. The method 800 may further include the following steps:receiving, via the single antenna, second telemetry signals in a thirdfrequency band that is substantially higher than the second frequencyband; charging a battery of the PNS device in response to the receivingof the inductive charging signals; waking up stimulation circuitry ofthe PNS device in response to the receiving of the second telemetrysignals; and generating, via the stimulation circuitry, a plurality ofelectrical pulses to be delivered to a patient for an electricalstimulation therapy.

It is understood that additional process steps may be performed before,during, or after the steps 810-830. For example, the method 800 mayinclude a step of rejecting, via a third circuit coupled to the singleantenna, the inductive charging signals and the first telemetry signalswhile allowing the second telemetry signals to pass through. As anotherexample, the method 800 may include a step of matching an impedance ofthe single antenna with an impedance of a telemetry chip via a pluralityof passive circuit elements in the second circuit, wherein the secondcircuit is coupled between the single antenna and the telemetry chip.For reasons of simplicity, other additional steps are not discussedherein. In addition, the steps 810-830 need not necessarily be performedaccording to the sequence shown in FIG. 18.

Method and Apparatus of Conserving Power for an Implantable PeripheralNeurostimulator

For implantable medical devices such as peripheral neurostimulators,battery life is one of the important considerations. An implantablemedical device with poor battery life may require frequent charging,which may diminish the user's satisfaction with the implantable medicaldevice. Many conventional neurostimulators, such as spinal cordstimulators, lack optimized power management. Therefore, in spite of therelatively large size and the accompanying onboard battery with arelatively big capacity, many conventional neurostimulators have poorbattery life performance.

In comparison, the PNS device 200 of the present disclosure has aminiature size (especially compared to conventional spinal cordstimulators) and therefore a smaller battery with limited capacity.Therefore, the present disclosure employs various advanced powerconservation strategies to maximize the battery life of the PNS device200, as discussed in more detail below. The advanced power conservationstrategies lead to excellent battery performance of the PNS device 200(e.g., lasting for weeks or months without needing a charge), in spiteof its miniature size.

One of the power conservation strategies of the PNS device 200 involvesoperating the microcontroller 400 (discussed above with reference toFIG. 7) in different power modes depending on the stage of thestimulation pulse. In more detail, the microcontroller 400 offers aplurality of different operating modes, where each operating mode may beused to performance a suitable task(s) and therefore has a differentpower consumption level. Table 1. below includes a brief listing of thedifferent operating modes:

Mode AM LPM4.5 Active, LPM3.5 Shutdown Shutdown FRAM LPM0 LPM1 LPM2 LPM3LPM4 RTC with without Active off CPU Off CPU Off Standby Standby Offonly SVS SVS Maximum 16 16 16 50 50 0 50 0 System MHz MHz MHz kHz kHzkHz Clock Typical 103 μA/ 65 μA/ 70 μA at 35 μA at 0.7 μA 0.4 μA 0.3 μA0.25 0.2 0.02 Current MHz MHz 1 MHz 1 MHz μA μA μA Consumption, T_(A) =25° C. Typical N/A Instant 6 μs 6 μs 7 μs 7 μs 250 250 1000 Wake-Up μsμs μs Time Wake-Up N/A All All LF LF I/O Comp RTC I/O I/O Events I/Ocomp I/O comp CPU On Off Off Off Off Off Reset Reset FRAM On Off StandbyOff Off Off Off Off Off (or off) High- Available Available Available OffOff Off Reset Reset Frequency Peripherals Low- Available AvailableAvailable Available Available Off RTC Reset Frequency PeripheralsUnclocked Available Available Available Available Available AvailableReset Reset Pheripherals MCLK On Off Off Off Off Off Off Off SMCLKOptional Optional Optional Off Off Off Off Off ACLK On On On On On OffOff Off Full Yes Yes Yes Yes Yes Yes No No Retention SVS Always AlwaysAlways Optional Optional Optional Optional On Off Brownout Always AlwaysAlways Always Always Always Always Always

In more detail, AM refers to an active mode of operation, where no powerconservation approaches are used. LPM0, LPM1, LPM2, LPM3, LPM4, LPM3.5,and LPM4.5 are the various power-conservation modes in which themicrocontroller 400 can operate. CPU refers to the microcontroller core410 (discussed above with reference to FIG. 7). MCLK is the main clock(clocked at 10 Mhz in this embodiment but may have a different clockrate in other embodiments, for example 20 Mhz) of the microcontroller400, ACLK is an auxiliary clock (clocked at 32.768 Khz in thisembodiment but may have a different clock rate in other embodiments) ofthe microcontroller 400, SMCLK is a sub-main clock of themicrocontroller 400, DCOCLK is a digitally-generated clock that isfeeding the main clock. In addition, DCO is a digitally-controlleroscillator, and FLL is a frequency-locked loop.

As is shown in Table 1, the microcontroller 400 turns on and off thevarious clocks and/or the peripherals of the microcontroller differentlyfor each of the operating modes. This is summarized briefly as follows:

Active mode (AM)

-   -   All clocks are active

Low-power mode 0 (LPM0)

-   -   CPU is disabled    -   ACLK and SMCLK remain active, MCLK is disabled    -   FLL loop control remains active

Low-power mode 1 (LPM1)

-   -   CPU is disabled    -   FLL loop control is disabled    -   ACLK and SMCLK remain active, MCLK is disabled

Low-power mode 2 (LPM2)

-   -   CPU is disabled    -   MCLK, FLL loop control, and DCOCLK are disabled    -   DCO's DC generator remains enabled    -   ACLK remains active

Low-power mode 3 (LPM3)

-   -   CPU is disabled    -   MCLK, FLL loop control, and DCOCLK are disabled    -   DCO's DC generator is disabled    -   ACLK remains active

Low-power mode 4 (LPM4)

-   -   CPU is disabled    -   ACLK is disabled    -   MCLK, FLL loop control, and DCOCLK are disabled    -   DCO's DC generator is disabled    -   Crystal oscillator is stopped    -   Complete data retention

As one example, the microcontroller 400 may operate in the LPM4power-conservation when the PNS device 200 is not in use. The LPM4 modeis also referred to as a “deep sleep” mode, where the microcontroller400 draws almost no current (i.e., consumes virtually no power). Themicrocontroller 400 has to be “woken up” from this deep sleep LPM4 modeby an external signal. By doing so, the deep sleep LPM4 mode allows themicrocontroller 400 to not waste power in standby.

As another example, the waveforms for the electrical stimulation pulsesare generated by the microcontroller 400's internal DAC(digital-to-analog converter) in real-time for each pulse. In betweenstimulation pulses—referred to as a standby period herein—themicrocontroller 400 enters one of the power-conservation modes (alsoreferred to as a low-power mode or sleep mode), for example the LPM3mode. This reduces power consumption, since many parts of themicrocontroller does not need to be turned on during the standby period.It is understood that the microcontroller 400 does not necessarily needto operate in the LPM3 throughout the entirety of the standby period inorder to realize the power savings. According to various embodiments ofthe present disclosure, the microcontroller 400 may operate in the LPM3power conservation mode in a substantial majority of the standby period,for example >75% of the standby period in some embodiments, or >90% ofthe standby period in some other embodiments, or >99% of the standbyperiod in yet some other embodiments.

When the microcontroller 400 enters the LPM3 power-conservation mode,the system clock switches from the main system clock (MCLK, which is 10MHz in this embodiment) to the crystal oscillator 430 (shown in FIG. 7)that is external to the microcontroller 400. The crystal oscillator 430has a clock frequency that is much lower than the main system clock, forexample with a clock frequency of 32.678 kHz in this case, compared tothe 10 Mhz clock frequency of the main system clock. Typically, a highclock frequency corresponds with more power consumption. Therefore,switching from a 10 Mhz clock to a 32.678 Khz clock also reduces powerconsumption.

Moreover, the microcontroller core 410 is turned off in the LPM3 mode.Meanwhile, the DMA unit 420 may be kept on (and is driven by the crystaloscillator 430) during the LPM3 mode to send instructions to variousperipherals, such as the DAC. For example, the DMA unit 420 may beconfigured to write the digital waveform data to the DAC. When thewriting of the digital waveform data into the DAC is complete, the DACoutputs the analog stimulation waveforms, i.e., the electricalstimulation pulse. Again, this process does not require themicrocontroller core 410 to be running. As discussed above, themicrocontroller core 410 is the main power-hog in the microcontroller400 and consumes substantially more power than the DMA unit 420.Consequently, turning off the microcontroller core 410, coupled with theswitching from the 10 Mhz main system clock to the 32.678 Khz clock ofthe crystal oscillator 430, allows the power consumption to be reducedfrom approximately 3 mA down to approximately 3 uA in some embodiments.In some embodiments, an interrupt signal generated by the timer unit 425(shown in FIG. 7)—clocked by the 32.768 kHz crystal oscillator 430—maybe used to wake the microcontroller 400 up from the LPM3 mode back tothe active mode in time to generate the next pulse

In addition, depending on the stimulation waveform type (active orpassive recovery), additional measures are employed to reduce powerconsumption. To illustrate, two example waveforms representing twodifferent types of a bi-phasic stimulation pulse are shown in FIGS.19-20. Specifically, the waveform in FIG. 19 shows a stimulation pulsewith a passive recovery, and the waveform in FIG. 20 shows a stimulationpulse with an active recovery. Generally, a bi-phasic stimulation pulseincludes a primary phase, an interphase, and a recovery phase. Theprimary phase is a period of time during which the actual stimulationpulse is generated. The recovery phase is a period of time to allowcharges on the electrodes to rebalance. The interphase is a period oftime between the primary phase and the recovery phase. For stimulationpulses with a passive recovery phase, the charges are passivelyrebalanced over time. In comparison, for stimulation pulses with anactive recovery phase, a “pulse” that is opposite in polarity (butsubstantially equal in amplitude) of the actual pulse (e.g., generatedin the primary phase) is generated to allow the charges to balance morequickly. Therefore, the trade-off between passive recovery and activerecovery is that passive recovery consumes less power but takes longer,and active recovery consumes more power but is quicker, which allows forstimulation at a higher frequency.

Referring now to FIG. 19, the primary phase, interphase, and the passiverecovery phase are clearly illustrated for a stimulation pulse withpassive recovery. In addition, portions of the standby period that is inbetween consecutive stimulation pulses are also illustrated. In someembodiments, the standby period may begin at the end of the recoveryphase and may last until the beginning of the primary phase for the nextpulse. It is understood that the standby period can be much longer thanthe actual pulse itself. For example, the time duration for an entirepulse—which includes the primary phase, interphase, and recoveryphase—may last from about 2 milli-seconds to about 4 milli-secondsaccording to some embodiments. In comparison, the time duration for thestandby period may last between about 1 milli-second to about 1 second.In other words, the standby period may be more than 4 to 10 times longerthan the actual pulse in some embodiments.

For most conventional neurostimulators, once a microcontroller is turnedon, it remains turned on during the stimulation pulses as well as inbetween the stimulation pulses. Stated differently, most conventionalneurostimulators keep the microcontroller turned on even during thestandby period. In comparison, the microcontroller 400 of the PNS device200 is turned on only when necessary. As FIG. 19 illustrates, themicrocontroller operates in the LPM3 power-conservation mode during mostof the standby period between consecutive stimulation pulses. Asdiscussed above, the microcontroller core 410 is turned off in the LPM3mode, which reduces power consumption significantly as themicrocontroller core 410 is a power-hungry device. Right before thepulse needs to be generated, the microcontroller 400 “wakes up” from theLPM3 power-conservation mode and begins to operate in the active mode(where the microcontroller core 410 is turned on). The waking of themicrocontroller 400 may be done by a timer signal generated by the timerunit 425, for example.

In the embodiment shown in FIG. 19, the microcontroller 400 wakes upfrom the LPM3 power-conservation mode and begins to operate in theactive mode about 100 micro-seconds before the start of the primaryphase. This is done so that the microcontroller 400 can enable thevoltage up-converter (e.g., a charge pump) 370 and the stimulationdriver 450 discussed above with reference to FIG. 7 in preparation forthe pulse generation. At some time after that, but still before thepulse is generated (before the start of the primary phase), themicrocontroller 400 sets or configures the multiplexers 460 so thatdesired stimulation channels can be formed. In the embodiment shown inFIG. 19, the multiplexers 460 are configured about 10 micro-secondsbefore the start of the primary phase.

Either the DMA unit 420 or the microcontroller core 410 may be used towrite the digital data for the stimulation waveform to the DAC. Once thedata has been completely written into the DAC, the stimulation pulse isgenerated by the DAC, thereby defining the start of the primary phase ofthe pulse. The stimulation pulse coming out of the DAC is amplified bythe stimulation driver 450 to achieve the target amplitude needed forthe peripheral stimulation therapy. In the illustrated embodiment, theamplified pulse amplitude ranges from about 0.1 V to about 12 V. Thestimulation driver 450 may also have a slew rate of about 2.3V/micro-seconds in the illustrated embodiment.

The pulse width, or the time duration of the primary phase, may beprogrammably configured. In various embodiments, the pulse width may bein a range from about 20 micro-seconds to about 2000 micro-seconds.Right before (or at) the end of the primary phase and before the startof the interphase, the multiplexers 460 are also disabled in order tofurther reduce power consumption. In the illustrated embodiment, themultiplexers 460 are disabled about 1 micro-second before the start ofthe interphase.

In the illustrated embodiment, the interphase may last for about 20micro-seconds. At the start of the interphase, or shortly after (e.g., afew micro-seconds), the voltage up-converter 370 is disabled to furtherreduce power consumption. The voltage up-converter 370 (e.g., a chargepump), when activated, supplies power to the stimulation driver 450 andthe multiplexers 460 when the stimulation pulse calls for a highervoltage than what the battery 340 can supply. For example, in thepresent embodiment, when the stimulation pulse needs to have anamplitude higher than about 3.5 V or 4 V, the battery 340 cannot supplythis high of voltage. The voltage up-converter 370 is then turned on toensure that the compliance voltage is sufficiently high. Forconventional neurostimulators, such voltage-converter (if it exists) istypically kept turned on to generate a constant high-voltage stimulationcompliance voltage, regardless of the phase of the stimulation pulse.This causes power to be wasted needlessly. In comparison, the voltageup-converter 370 of the PNS device 200 can be enabled shortly before(e.g., a few microseconds) the stimulation pulse is generated anddisabled just after (e.g., a few microseconds) the stimulation pulse isgenerated. By doing so, steady-state power consumption of the PNS device200 is reduced significantly.

Similarly, the stimulation driver 450 can be enabled shortly before(e.g., a few microseconds) the stimulation pulse is generated anddisabled shorty after (e.g., a few microseconds) the stimulation pulseis generated. Again, the timely enabling and disabling of thestimulation driver 450 prevents power from being wasted needlesslyoutside the primary phase of the stimulation pulse.

Shortly before the end of the interphase and before the start of thepassive recovery phase, the multiplexers 460 are turned on but grounded.This allows the electrical charge that has been built up on thecapacitors 465 to discharge back into the tissue. In the illustratedembodiment, the grounding of the multiplexers 460 occurs about 1micro-second before the recovery phase. The recovery phase is passivebecause the built-up charges are just “passively” being discharged toperform charge balancing, so as to achieve zero voltage on theelectrodes at the end of the passive recovery phase. In the illustratedembodiment, the passive recovery phase may last for about 2 to 6milli-seconds.

At the end (or shortly after) of the passive recovery phase, themultiplexers 460 are disabled (e.g., they may go into a high impedancemode) in order to further reduce power consumption. This marks the endof one cycle of the bi-phasic pulse, and the standby period follows theend of the previous pulse (and before the start of the subsequentpulse). To further reduce power consumption, the timer unit 425instructs the microcontroller 400 to enter or operate in the LPM3 modeagain during the standby period. This process discussed above may repeatindefinitely for each passive stimulation pulse cycle until stimulationis shut off.

Referring now to FIG. 20, the operation of the PNS device 200 for activerecovery stimulation shares many similarities with the passive recoverystimulation discussed above with reference to FIG. 19, with certaindifferences. In more detail, up to the point of the interphase, theoperation/configuration of the microcontroller 400 and the various othercomponents of the PNS device 200 are substantially identical for passiverecovery stimulation and active recovery stimulation. However, whereasthe voltage up-converter 370 and the stimulation driver 450 are disabledat or shortly after the start of the interphase for passive recoverystimulation, the voltage up-converter 370 and the stimulation driver 450remain turned on during the interphase for active recovery stimulation.In addition, whereas the multiplexers 460 are grounded before the startof the recovery phase for passive recovery stimulation, the multiplexers460 are actually configured before (e.g., about 1 milli-seconds before)the recovery phase for active recovery stimulation. These differencesreflect the fact that another pulse needs to be generated during therecovery phase for active recovery stimulation.

For example, the microcontroller core 410 or the DMA unit 420 writesdigital waveform data into the DAC during the interphase, and at thecompletion of this data writing process, the DAC outputs a stimulationpulse that is substantially equal in pulse width but opposite inpolarity with the actual stimulation pulse generated in the primaryphase. The generation of this “opposite” pulse corresponds to the activerecovery phase. The active recovery phase is thus much shorter than thepassive recovery phase, which may allow for a higher stimulationfrequency.

Since the active recovery phase require pulse generation during therecovery phase, the microcontroller 400 operates in the active mode forthe entire 3 phases of the stimulation pulse (i.e., the primary phase,the interphase, and the active recovery phase). Furthermore, the voltageup-converter 370 and the stimulation driver 450 remain turned on duringthe entire 3 phases of the stimulation pulse to ensure voltagecompliance and to amplify the stimulation pulse outputted by the DAC.

At the end of the active recovery phase, or shortly thereafter (e.g., afew micro-seconds thereafter), the multiplexers 460 are disabled, andthe voltage up-converter 370 and the stimulation driver 450 are alsodisabled. The microcontroller 400 also reverts back to the LPM3power-conservation mode after the end of the active recovery phase. Inother words, these power-consuming components are disabled in thestandby period (or at least a substantial majority thereof) betweenconsecutive pulses in order to conserve power. This process discussedabove may repeat for each active recovery stimulation pulse indefinitelyuntil stimulation is shut off.

It is understood that the active mode and the LPM3 power conservationmode are used as mere examples herein to illustrate certain aspects ofthe power reduction strategies of the PNS device 200. In otherembodiments, any of the other power-conservation modes may also beemployed to reduce power consumption. For example, in some embodiments,the microcontroller core 410 may be turned off during one or more of thephases within a pulse, and the DMA unit 420 may be used to perform othertasks instead of the microcontroller core 410, such as writing data tothe DAC.

The above discussions pertain to power reduction achieved by selectivelyoperating the microcontroller 400 in a power-conservation mode wheneverappropriate, as well as timely disabling and enabling power-consumingcomponents such as the voltage up-converter 370, the stimulation driver450, and the multiplexers 460 throughout the different phases of thestimulation pulse. In other words, the PNS device 200 micro-manages thevarious power-consuming components within to ensure that no power isneedlessly wasted.

Another example of the micromanagement used to conserve power pertainsto disconnecting the voltage up-converter 370 from its load (e.g., thestimulation driver 450 and the multiplexers 460) between consecutivestimulation pulses (i.e., during the standby period). In more detail,the voltage up-converter 370 may employ an output capacitor to storecharge. Even if the voltage up-converter 370 is turned off between thestimulation pulses (during the standby period), any load connected tothe output capacitor may still drain the charge out of the outputcapacitor. In other words, the stimulation driver 450 and themultiplexers 460 herein may serve as the load that will cause the outputcapacitor of the voltage up-converter 370 to discharge. This means thatwhen the voltage up-converter is turned on the next time, it will haveto charge up the output capacitor again, thereby wasting power.

According to various embodiments of the present disclosure, the switch480 (discussed above with reference to FIG. 7) can be used to disconnectthe stimulation driver 450 and the multiplexers 460 (i.e., the load ofthe voltage up-converter 370) from the voltage up-converter during thestandby period, even as the voltage up-converter 370, the stimulationdriver 450, and the multiplexers 460 are turned off. By timelydisconnecting the load from the voltage up-converter 370, energy (i.e.,electrical charge) stored in the voltage up-converter 370 may bepreserved for the next stimulation pulse.

It is understood that in some embodiments, the timer unit 425 (or thetimer signals generated therefrom) may be used to control the timing forthe micromanage tasks discussed above, i.e., switching themicrocontroller 400 between the active mode and one of thepower-conservation modes, enabling/disabling the voltage up-converter370, the stimulation driver 450, and the multiplexers, disconnecting theload from the voltage up-converter 370, and/or writing to the DAC. Thetimer unit 425 may be programmed by firmware or software to performthese tasks.

It is also understood that although a typical bi-phasic pulse is usedherein as an example of a stimulation pulse, the concepts discussedherein may apply to other types of stimulation pulses as well. Forexample, certain types of stimulation pulses may have a plurality ofpulses in the primary phase before the interphase and the recoveryphase. Even for these types of stimulation pulses, the microcontroller400 may still switch its mode of operation in the standby period, andthe other components such as the voltage up-converter and stimulationdrive may still be micromanaged appropriately in order to reduce powerconsumption. Furthermore, although the embodiment shown in FIGS. 19-20illustrate operating the microcontroller 400 in the active mode duringthe pulse generation, the microcontroller 400 may also operate in one ormore of the other power-conservation modes (e.g., the LPM1 mode) evenduring the pulse generation in order to further reduce powerconsumption.

FIG. 21 is a simplified flowchart of a method 900 of providing anelectrical stimulation therapy for a patient according to an embodimentof the present disclosure. The method 900 includes a step 905 ofreceiving programming instructions from an electronic programmer.

The method 900 includes a step 910 of generating, via a microcontrollerand in response to the received programming instructions, a plurality ofelectrical pulses to be delivered to the patient as a part of theelectrical stimulation therapy. Each electrical pulse includes a primaryphase, an interphase after the primary phase, and a recovery phase afterthe primary phase. Consecutive electrical pulses are separated by astandby period. The step 910 of generating of the electrical pulsescomprises: operating the microcontroller in an active mode during atleast one of: the primary phase and the interphase; and operating themicrocontroller in a power-conservation mode during a substantialmajority of the standby period. The microcontroller consumessubstantially less power when operating in the power-conservation modethan in the active mode. In some embodiments, the microcontroller is themicrocontroller 400 of FIG. 7.

The method 900 includes a step 915 of receiving an inductive energy. Insome embodiments, the inductive energy is received via a coil, forexample by the conductive charging mechanism 320 of FIG. 7 (anembodiment of which is illustrated as the coil 700 of FIGS. 15A-15C).

The method 900 includes a step 920 of converting the inductive energyinto a direct current (DC) signal. In some embodiments, the convertingof the inductive energy is performed by the charging circuit 330 of FIG.7.

The method 900 includes a step 925 of charging a battery with the DCsignal, thereby providing a first DC voltage via the battery. In someembodiments, the battery is the battery 340 of FIG. 7, and the firstvoltage is the output voltage of the battery 340.

The method 900 includes a step 930 of down-converting the first DCvoltage to a second DC voltage smaller than the first DC voltage. Insome embodiments, the down-converting is performed by the voltagedown-converter 360 of FIG. 7, and the second DC voltage is the outputvoltage of the voltage down-converter 360. In some embodiments, thevoltage down-converter 360 includes a buck converter.

The method 900 includes a step 935 of providing the second DC voltage asa voltage supply for at least the microcontroller.

The method 900 includes a step 940 of up-converting the first DC voltageto a third DC voltage greater than the first DC voltage. In someembodiments, the up-converting is performed by the voltage up-converter370 of FIG. 7, and the third DC voltage is the output voltage of theup-converter 370. In some embodiments, the voltage down-converter 370includes a charge pump.

The method 900 includes a step 945 of providing the third DC voltage asa voltage supply for a stimulation driver and an array of multiplexerscoupled to the stimulation driver. In some embodiments, the stimulationdriver is the stimulation driver 450 of FIG. 7, and the array ofmultiplexers includes the multiplexers 460 of FIG. 7.

The method 900 includes a step 950 of amplifying, via the stimulationdriver, the electrical pulses generated by the microcontroller.

The method 900 includes a step 955 of delivering the amplifiedelectrical pulses to the patient at least in part by configuring thearray of multiplexers.

The method 900 includes a step 960 of disconnecting the stimulationdriver from the voltage up-converter during the standby period betweenconsecutive electrical pulses. In some embodiments, the disconnecting isperformed at least in part by the switch 480 of FIG. 7.

In some embodiments, the microcontroller of the method 900 contains amicrocontroller core (e.g., the microcontroller core 410 of FIG. 7) anda direct memory access (DMA) unit (e.g., the DMA unit 420 of FIG. 7)that is separate from the microcontroller core and consumessubstantially less power than the microcontroller core. In theseembodiments, the operating of the microcontroller may comprises a stepof turning on the microcontroller core in the active mode, turning offthe microcontroller core in the power-conservation mode, and keeping theDMA unit turned on in the power-conservation mode. In some embodiments,the microcontroller contains a system clock that is running at a firstfrequency, and the stimulation circuitry further comprises an oscillatorthat is external to the microcontroller. The oscillator runs at a secondfrequency that is substantially lower than the first frequency. In theseembodiments, the operating of the microcontroller comprises driving themicrocontroller with the system clock in the active mode. The DMA unitis also driven with the oscillator in the power-conservation mode. Inaddition, the method 900 may include a step of generating an interruptsignal with a timer unit (e.g., the timer unit 425 of FIG. 7) that isclocked by the oscillator, and a step of waking up the microcontrollerfrom the power-conservation mode via the interrupt signal immediatelybefore a subsequent electrical pulse needs to be generated.

It is understood that the steps 905-960 need not necessarily beperformed according to the sequence shown in FIG. 21. In fact, some ofthese steps may be performed concurrently, or even in an order differentfrom what is shown in FIG. 21. It is also understood that additionalprocess steps may be performed before, during, or after the steps905-960. For example, as each electrical pulse may include either apassive recovery phase or an active recovery phase, different processsteps may be performed depending on whether the electrical pulse has apassive recovery phase or an active recovery phase. If the electricalpulse has a passive recovery phase, then the method 900 may include astep of enabling the voltage up-converter and the array of multiplexersbefore the primary phase, a step of disabling the voltage up-converterand the array of multiplexers during the interphase, and a step ofoperating the microcontroller in the power-conservation mode during thepassive recovery phase. If the electrical pulse as an active recoveryphase, then the method 900 may include a step of enabling the voltageup-converter and the array of multiplexers before the primary phase, astep of disabling the voltage up-converter and the array of multiplexersafter the active recovery phase, and a step of operating themicrocontroller in the active mode during the active recovery phase. Forreasons of simplicity, other additional steps are not discussed herein.

The foregoing has outlined features of several embodiments so that thoseskilled in the art may better understand the detailed description thatfollows. Those skilled in the art should appreciate that they mayreadily use the present disclosure as a basis for designing or modifyingother processes and structures for carrying out the same purposes and/orachieving the same advantages of the embodiments introduced herein.Those skilled in the art should also realize that such equivalentconstructions do not depart from the spirit and scope of the presentdisclosure, and that they may make various changes, substitutions andalterations herein without departing from the spirit and scope of thepresent disclosure.

What is claimed is:
 1. A medical system, comprising: an implantable leadconfigured to deliver an electrical stimulation therapy for a patient,wherein the lead includes: an elongate lead body that is configured tobe coupled to a pulse generator that generates electrical stimulationspulses as part of the electrical stimulation therapy; and a paddlecoupled to the lead body; wherein: the paddle contains a plurality ofelectrodes that are each configured to deliver the electricalstimulation pulses to target nerves of the patient; the plurality ofelectrodes are arranged into at least three columns that each include arespective subset of the electrodes, each subset containing a respectiveplurality of the electrodes; and the plurality of electrodes eachincludes a unique centerline, wherein the centerlines extend indirections transverse to the columns.
 2. The medical system of claim 1,further comprising a peripheral nerve stimulation (PNS) device that isconfigured to generate the electrical stimulation pulses, wherein thelead body is configured to be attached to the PNS device.
 3. The medicalsystem of claim 1, wherein: the centerlines are first centerlines; andthe electrodes each include a unique second centerline that isperpendicular to the first centerline.
 4. The medical system of claim 1,wherein: the electrodes collectively define a stimulation region withinthe paddle; and no linear path across the stimulation region existswithout intersecting at least one of the electrodes.
 5. The medicalsystem of claim 1, wherein: the columns each extend along a respectivefirst direction; and the centerline of each electrode each extend alonga second direction different from the respective first directions. 6.The medical system of claim 5, wherein the respective first directionsare parallel to one another and are each perpendicular to the seconddirection.
 7. The medical system of claim 5, wherein at least one of thefirst directions is non-perpendicular with the second direction.
 8. Themedical system of claim 7, wherein the respective first directions arenot parallel with one another.
 9. The medical system of claim 1, whereineach of the electrodes overlaps with at least one other electrode in afirst direction and at least another electrode in a second directiondifferent from the first direction.
 10. A medical system, comprising: animplantable lead configured to deliver an electrical stimulation therapyfor a patient, wherein the lead includes: an elongate lead body that isconfigured to be coupled to a pulse generator that generates electricalstimulations pulses as part of the electrical stimulation therapy; and apaddle coupled to the lead body; wherein: the paddle contains aplurality of electrodes that are each configured to deliver theelectrical stimulation pulses to the patient; the plurality ofelectrodes each have a respective first centerline extending along afirst direction and a respective second centerline extending along asecond direction different from the first direction; each of theelectrodes overlaps with at least one other electrode in a firstdirection and at least another electrode in a second direction differentfrom the first direction; a substantial majority of the firstcenterlines are not aligned in the first direction with any of the otherfirst centerlines; and a substantial majority of the second centerlinesare not aligned in the second direction with any of the other secondcenterlines.
 11. The medical system of claim 10, further comprising aperipheral nerve stimulation (PNS) device that is configured to generatethe electrical stimulation pulses, wherein the lead body is configuredto be attached to the PNS device.
 12. The medical system of claim 10,wherein the first direction is perpendicular to the second direction.13. The medical system of claim 10, wherein the plurality of electrodesare arranged into at least three columns that extend roughly in thefirst direction or at least three rows that extend roughly in the seconddirection.
 14. The medical system of claim 10, wherein: the electrodescollectively define a stimulation region on the paddle; and asubstantial majority of straight lines drawn across the stimulationregion will intersect at least one of the electrodes.
 15. The medicalsystem of claim 14, wherein no straight line extending in the first orsecond directions can be drawn across the stimulation region withoutintersecting at least one of the electrodes.
 16. A medical system,comprising: an implantable lead configured to deliver an electricalstimulation therapy for a patient, wherein the lead includes: anelongate lead body that is configured to be coupled to a pulse generatorthat generates electrical stimulations pulses as part of the electricalstimulation therapy; and a paddle coupled to the lead body; wherein: thepaddle contains a plurality of electrodes that are each configured todeliver the electrical stimulation pulses to the patient; the electrodescollective define a stimulation region on the paddle; and every linearpath across the stimulation region intersects with at least one of theelectrodes.
 17. The medical system of claim 16, further comprising aperipheral nerve stimulation (PNS) device that is configured to generatethe electrical stimulation pulses, wherein the lead body is configuredto be attached to the PNS device.
 18. The medical system of claim 16,wherein: the plurality of electrodes each include a respective firstcenterline extending along a first axis; and none of the firstcenterlines intersect with any of the other first centerlines.
 19. Themedical system of claim 18, wherein: the plurality of electrodes eachfurther include a respective second centerline extending along a secondaxis that is different from the first axis; and none of the secondcenterlines intersect with any of the other second centerlines.
 20. Themedical system of claim 19, wherein the first axis is perpendicular tothe second axis.